DailyMed - DIPHEN- benzocaine, benzalkonium chloride, lidocaine hydrochloride, hydrocortisone, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, calcium carbonate, ibuprofen, loratadine, acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, diphenhydramine hydrochloride, potassium chloride, magnesium oxide, meclizine hydrochloride, and bismuth subsalicylate kit

NDC Code(s): 82652-021-01, 82652-022-01, 82652-023-01, 82652-024-01, view more
82652-025-01, 82652-026-01, 82652-027-01, 82652-028-01, 82652-029-01, 82652-030-01, 82652-031-01, 82652-032-01, 82652-033-01
Packager: Remedy Pack LLC

Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 11, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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SPL UNCLASSIFIED SECTION

REMEDY PACK
SPL UNCLASSIFIED SECTION

Burn Cream

Drug Facts
INGREDIENTS

Active ingredients

Benzalkonium Chloride 0.13%, Lidocaine HCl 0.5%

Purpose

Topical antiseptic, Topicall analgesic
USES
First aid to help prevent infection in minor cuts, scrapes and burns.

For the temporary relief of pain and itching associated with:
- sunburn
- insect bites
- cuts
- minor skin irritations
- scrapes
- minor burns
WARNING
For external use only.
Do not use
- in the eyes
- over large areas of the body or on deep puncture wounds, animal bites, or serious burns
- in large quantities, particularly over raw surfaces or blistered areas
Stop use and ask doctor if
- the condition gets worse
- condition clears up and recurs within a few days
- condition persists for more than 7 days
If pregnant or breast feeding, ask a health care professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.
DIRECTIONS
Adults and children 2 years and over:
- clean the affected area
- apply a small amount of this product on the area 3 to 4 times daily
- may be covered with a sterile bandage
- Children under 12 years: consult a doctor
- Children under 2 years: consult a doctor
OTHER INFORMATION
- store in a cool, dry area 59° to 79°F (15° to 25°C)
- tamper evident sealed packets
- do not use any opened or torn packets
INACTIVE INGREDIENTS

decolorized aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax
SPL UNCLASSIFIED SECTION

Triple Antibiotic

Drug Facts
INGREDIENTS

Active Ingredient (in each gram)

Bacitracin zinc (400 units), Neomycin sulfate 5 mg (equivalent to 3.5 mg of Neomycin), Polymyxin-B sulfate 5000 units

Purposes

First aid antibiotics
USES
First aid to help prevent infection in:
- minor cuts
- scrapes
- burns
WARNING
- For external use only
Do not use
- in the eyes
- over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor
Ask a doctor before use

in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

the condition persists or gets worse a rash or other allergic reaction develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.
DIRECTIONS

clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
may be covered with a sterile bandage
OTHER INFORMATION
- store at room temperature 15°C to 30°C (59°F to 86°F) (do not freeze) tamper evident. Do not use if packet is torn, cut or opened.
- avoid excessive heat and humidity
INACTIVE INGREDIENTS

mineral oil, white petrolatum
SPL UNCLASSIFIED SECTION

Hydrocortisone Cream

Drug Facts
INGREDIENTS

Active Ingredient (in each gram)

Hydrocortisone 1.0%

Purpose

Anti-Itch
USES
- eczema
- insect bites
- poison ivy
- Poison oak
- poison sumac
- Cosmetics
- jewelry
- soaps detergents
- seborrheic
- dermatitis
- Psoriasas
Other uses of this product should only be under the advice and supervision of a doctor.
WARNING
- For external use only
- avoid contact with the eyes
- if condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor
- do not use for the treatment of diaper rash.
- Keep out of reach of children.
- If swallowed, get medical help or consult a poison control center right away.
DIRECTIONS

Adult and children (2 years and over): apply to affected not more than 3 to 4 times daily

Children under 2 years: Consult a doctor.
OTHER INFORMATION
- store at room temperature 59-86ºF (15-30ºC)
- do not freeze
- do not use any opened or torn packets.
INACTIVE INGREDIENTS

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white Wax.
SPL UNCLASSIFIED SECTION

Oral Pain Relief Gel

Drug Facts
INGREDIENTS

Active ingredients

Benzocaine 20%

Purpose

Oral Anesthetic
USES

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
WARNINGS
METHEMOGLOBINEMIA WARNING

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood.

This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
ALLERGY ALERT

do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other " caine" anesthetics.
Do not use

For more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.
- for teething
- in children under 2 years of age
When using this product

avoid contact with eyes. If it occurs, flush with water.
Do not exceed recommended dosage.
- If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center right away.
- If pregnant or breast feeding,ask a health care professional before use.
- Keep out of reach of children.
DIRECTIONS
- Apply only amount needed to the oral mucosa to prevent or relieve pain.
- children under 2 years of age: do not use
OTHER INFORMATION
- store at room temperature 15°C to 30°C (59°F to 86°F)
- protect from freezing
INACTIVE INGREDIENTS

Flavoring, PEG 3350, PEG 400, sodium sacchrin, water.

May contain blue #1, green #3, green #5 , red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as color additive.
SPL UNCLASSIFIED SECTION

Alcalak

Drug Facts
INGREDIENTS

Active ingredient (in each tablet)

Calcium Carbonate 420mg

Purpose

Antacid
INACTIVE INGREDIENTS1

aspartame1, croscarmellose sodium1, gum acacia1, magnesium stearate, maltodextrin, mineral oil1, mint flavor, sorbitol1, sucrose1

1

may contain
USES
For the relief of the following symptoms associated with
- acid indigestion
- sour stomach
- heartburn
- upset stomach
WARNING
Do not use
- the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician, or take more than 19 tablets in a 24 hour period.
Ask a doctor or pharmacist before use if you are
- presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Stop use and ask a doctor if
- symptoms last more than 2 weeks
If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.
DIRECTIONS
- do not use more than directed
Adults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not exceed 19 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.
OTHER INFORMATION
- Phenylketonurics: contains phenylalanine 1.5mg per tablet
- each tablet contains 168mg of elemental calcium
- store at room temperature 59º-86ºF (15º-30ºC) in a dry place
- tamper-evident sealed packets
- do not use any opened or torn packets
SPL UNCLASSIFIED SECTION

Cold Relief

Drug Facts

INGREDIENTS

Active ingredient (in each tablet): Acetaminophen 325mg	Purpose: Pain reliever/ fever reducer
Active ingredient (in each tablet): Dextromethorphan Hydrobromide 15mg	Purpose: Cough suppressant
Active ingredient (in each tablet): Guaifenesin 200mg	Purpose: Expectorant
Active ingredient (in each tablet): Phenylephrine HCl 5mg	Purpose: Nasal decongestant

INACTIVE INGREDIENTS*

maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid
USES
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
- cough
- sore throat
- minor aches and pains
- headache
- nasal congestion
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Temporarily reduces fever.
WARNING
Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you have ever had an allergic reaction to this product or any of the ingredients.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
When using this product
- do not use more than directed
Stop use and ask a doctor if
- new symptoms occur
- redness or swelling is present
- pain or nasal congestion gets worse or lasts for more than 7 days
- fever gets worse or lasts for more than 3 days
- you get nervous, dizzy or sleepless
- cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
DIRECTIONS

Adults and children: (12 years and older) Take 2 tablets with water every 6- 8 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.
OTHER INFORMATION
- store at room temperature 59º-86ºF (15º-30ºC)
- avoid excessive heat and humidity
- tamper-evident sealed packets
- do not use any opened or torn packets
SPL UNCLASSIFIED SECTION

Medi-Meclizine

Drug Facts
INGREDIENTS

Active ingredient (in each tablet)

Meclizine Hydrochloride 25mg

Purpose

Antiemetic
INACTIVE INGREDIENTS*

anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
USES

For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.

For the reduction of fever.
WARNING
Do not use
- for children under 12 years of age unless directed by a doctor
- for frequent or prolonged use except under the advice of a doctor
Ask a doctor before use if you have
- breathing problems such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland if you are
- taking sedatives or tranquilizers
When using this product
- drowsiness may occur
- alcohol, sedatives and tranquilizers may increase the drowsiness effect
- avoid alcoholic beverages while taking this product
- use caution when driving a motor vehicle or operating machinery
Do not exceed recommended dosage.
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DIRECTIONS
- do not use more than directed
- to prevent motion sickness, take the first dose one hour before starting activity
Adults and children: (12 years and older) 1 to 2 tablets once daily or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.
OTHER INFORMATION
- store at room temperature 59- 86º F (15-30ºC)
- tamper-evident sealed packets
- do not use any opened or torn packets
SPL UNCLASSIFIED SECTION

I-Prin

Drug Facts
INGREDIENTS

Active ingredient (in each tablet)

Ibuprofen (NSAID2) 200mg

2

nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer
INACTIVE INGREDIENTS3

carnauba wax3, corn starch, hypromellose3, iron oxide red, lactose3, magnesium stearate3, microcrystalline cellulose3, polydextrose3, polyethylene glycol, polyvinyl alcohol3, povidone (K-30)3, silicon dioxide, sodium starch glycolate, stearic acid, talc3, titanium dioxide

3

may contain
USES
Temporarily relieves minor aches and pains associated with
- headache
- toothache
- backache
- menstrual cramps
- common cold
- muscular aches
- minor arthritis pain
Temporarily reduces fever.
WARNING
Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:
- hives
- skin reddening
- facial swelling
- rash
- asthma (wheezing)
- blisters
- shock
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Heart attack or stroke warning: NSAIDS, except aspirin, increase the risk of heart attack, heart failure, and stroke.

These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
- if you have ever had an allergic reaction to any other pain reliever/ fever reducer
- right before or after heart surgery
Ask a doctor before use if
- you have problems or serious side effects from taking pain relievers or fever reducers
- stomach bleeding warning applies to you
- you have a history of stomach problems such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- under a doctor's care for any serious condition
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
  
  -
  
  feel faint
  
  -
  
  vomit blood
  
  -
  
  have bloody or black stools
  
  -
  
  have stomach pain that does not get better
- you have symptoms of heart problems or stroke
  
  -
  
  chest pain
  
  -
  
  trouble breathing
  
  -
  
  weakness in one part or side of body
  
  -
  
  slurred speech
  
  -
  
  leg swelling
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new or unexpected symptoms occur
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DIRECTIONS
- do not take more than directed
- the smallest effective dose should be used
- do not take longer than 10 days, unless directed by a doctor (see Warnings)
Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.
OTHER INFORMATION
- read all product information before using
- store at 68-77°F (20-25°C)
- avoid excessive heat 104°F (above 40°C)
- tamper-evident sealed packets
- do not use any opened or torn packets
SPL UNCLASSIFIED SECTION

Diphen

Drug Facts
INGREDIENTS

Active ingredient (in each tablet)

Diphenhydramine HCl 25mg

Purpose

Antihistamine
INACTIVE INGREDIENTS4

carnauba wax4, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate4, hypromellose, lactose4, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate4, titanium dioxide

4

may contain
USES

Active ingredients

Diphenhydramine HCl 25mg

Purpose

Antihistamine

Inactive Ingredients5

carnauba wax5, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate5, hypromellose, lactose5, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate5, titanium dioxide

5

may contain
WARNING
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one that is used on skin
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- glaucoma
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
When using this product
- marked drowsiness may occur
- avoid alcohol beverages
- alcohol, sedatives and tranquilizers may increase the drowsiness effect
- use caution when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center immediately.
DIRECTIONS
- do not use more than directed
Adults and children: (12 years and older) Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.
OTHER INFORMATION
- each caplet may contain: calcium 25mg
- protect from light
- use by expiration date on packet
- store at room temperature 59º-86ºF (15º-30ºC)
- tamper-evident sealed packets
- do not use any opened or torn packets
SPL UNCLASSIFIED SECTION

Extra Strength APAP

Drug Facts
INGREDIENTS

Active ingredient (in each tablet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer
INACTIVE INGREDIENTS6

corn starch, hypromellose, maltodextrin6, microcrystalline cellulose6, polyethylene glycol, povidone6, pregelatinized starch6, sodium starch glycolate6, stearic acid, titanium dioxide6

6

may contain
USES
For the temporary relief of minor aches and pains associated with
- headache
- muscular aches
- minor arthritis pain
- common cold
- toothache
- menstrual cramps
For the reduction of fever.
WARNING
Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 tablets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
Ask a doctor before use if you have
- liver disease
Ask a doctor or pharmacist before use if
- you are taking the blood thinning drug warfarin
Stop using and ask a doctor if
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
- redness or swelling is present
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
DIRECTIONS
- do not use more than directed
Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
OTHER INFORMATION
- store at room temperature 59º-86ºF (15º-30ºC)
- tamper-evident sealed packets
- do not use any opened or torn packets
SPL UNCLASSIFIED SECTION

Loradamed

Drug Facts
INGREDIENTS

Active ingredient (in each tablet)

Loratadine 10mg

Purpose

Antihistamine
INACTIVE INGREDIENTS*

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch
USES
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
WARNING
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor if
- an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
DIRECTIONS

Adults and children: (12 years and older) Take 1 tablet daily; not more than 1 tablet in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Consumers with liver or kidney disease: Ask a doctor before using.
OTHER INFORMATION
- store at room temperature 68º-77ºF (20º-25ºC)
- protect from excessive moisture
- tamper-evident sealed packets
- do not use any opened or torn packets
SPL UNCLASSIFIED SECTION

Medi-Lyte

Drug Facts

INFORMATION

Serving Size: 2 tablets

Servings Per Packet: 1

OTHER INGREDIENTS

microcrystalline cellulose, silicon dioxide, stearic acid, magnesium stearate

Amount Per Serving	% Daily Value
Calcium (from 27.0 mg calcium carbonate) 10.8 mg	1.06%
Potassium (from 80 mg potassium chloride) 40mg	1.15%
Magnesium (from 20 mg magnesium oxide) 12 mg	3.0%
Carbohydrates 6 mg	>1%
Calories 1.5	>1%
Protein	0%
Fat	0%

USES
Nutritional support for the following symptoms due to excessive loss of perspiration
- heat fatigue
- muscle cramps
- heat exhaustion
- heat stroke
- replaces lost electrolytes
- helps provide rapid rehydration
*This statement has not been evaluated by the Food and Drug administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
WARNING

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DIRECTIONS
Adults and children: (12 years and older)
- take 2 tablets as needed with a full glass of water
- may be repeated every hour as needed
- do not exceed 20 tablets in 24 hours
Children under 12 years:
- Do not give to children under 12 years of age
OTHER INFORMATION
- store at room temperature 59º-86º F (15º-30º C)
- avoid excessive heat and humidity
- tamper-evident sealed packets
- do not use any opened or torn packets
- no sodium added
SPL UNCLASSIFIED SECTION

Diotame

Drug Facts
INGREDIENTS

Active ingredient (in each tablet)

Bismuth Subsalicylate 262mg (each tablet contains 102mg salicylate)

Purpose

Upset stomach reliever/antidiarrheal
INACTIVE INGREDIENTS*

acacia gum, aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide
USES
Temporarily relieves
- travelers' diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including
  
  -
  
  heartburn
  
  -
  
  indigestion
  
  -
  
  nausea
  
  -
  
  gas
  
  -
  
  belching
  
  -
  
  fullness
WARNING
Reye's syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome a rare but serious illness.
Allergy alert

Contains salicylate. Do not take if you are:
- allergic to salicylates (including aspirin)
- taking other salicylate products
Do not use if you have
- bloody or black stool
- an ulcer
- a bleeding problem
Ask a doctor before use if you have
- fever
- mucus in the stool
Ask a doctor or pharmacist if you are taking any drug for
- anticoagulation (thinning of the blood)
- diabetes
- gout
- arthritis
Stop use and ask a doctor if
- symptoms get worse
- ringing in the ears or loss of hearing occurs
- diarrhea lasts more than 2 days
When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena.

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately.
DIRECTIONS
- do not use more than directed
- chew or crush tablets completely before swallowing
- do not swallow tablets whole
- use until diarrhea stops but not more than 2 days
- drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
- do not exceed 16 tablets in 24 hours
Adults and children: (12 years and older) Chew 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed.

Children under 12 years: Do not give to children under 12 years of age.
OTHER INFORMATION
- Phenylketonurics: contains phenylalanine 1.1mg per tablet
- each tablet contains 73mg of elemental calcium
- store at room temperature 59º-86ºF (15º-30ºC)
- tamper-evident sealed packets
- do not use any opened or torn packets
PRINCIPAL DISPLAY PANEL - Kit Carton

REMEDY PACK

DRUG FACTS

www.theremedypack.com

INGREDIENTS AND APPEARANCE

DIPHEN
benzocaine, benzalkonium chloride, lidocaine hydrochloride, hydrocortisone, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, calcium carbonate, ibuprofen, loratadine, acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, diphenhydramine hydrochloride, potassium chloride, magnesium oxide, meclizine hydrochloride, and bismuth subsalicylate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82652-021

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82652-021-01	1 in 1 CARTON	05/10/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	4 PACKET	3 g
Part 2	2 PACKET	1.8 g
Part 3	4 PACKET	3.6 g
Part 4	8 PACKET	4 g
Part 5	2 PACKET	4
Part 6	4 PACKET	8
Part 7	4 PACKET	4
Part 8	4 PACKET	8
Part 9	4 PACKET	4
Part 10	2 PACKET	4
Part 11	3 PACKET	6
Part 12	4 PACKET	8
Part 13	3 PACKET	6

Part 1 of 13

PAIN RELIEF
benzocaine liquid

Product Information
Item Code (Source)	NDC:82652-033(NDC:61010-8100)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5)	benzocaine	200 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
polyethylene glycol 400 (UNII: B697894SGQ)
polyethylene glycol 3350 (UNII: G2M7P15E5P)
peppermint oil (UNII: AV092KU4JH)
saccharin sodium (UNII: SB8ZUX40TY)
sorbic acid (UNII: X045WJ989B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82652-033-01	0.75 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	05/01/2010

Part 2 of 13

BURN
benzalkonium chloride and lidocaine hydrochloride cream

Product Information
Item Code (Source)	NDC:82652-029(NDC:47682-940)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	1.3 mg in 1 g
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Alcohol (UNII: 3K9958V90M)
Methylparaben (UNII: A2I8C7HI9T)
Mineral Oil (UNII: T5L8T28FGP)
Paraffin (UNII: I9O0E3H2ZE)
Propylparaben (UNII: Z8IX2SC1OH)
Water (UNII: 059QF0KO0R)
White Petrolatum (UNII: B6E5W8RQJ4)
White Wax (UNII: 7G1J5DA97F)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82652-029-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	08/29/2017

Part 3 of 13

HYDROCORTISONE
hydrocortisone cream

Product Information
Item Code (Source)	NDC:82652-027(NDC:47682-923)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Alcohol (UNII: 3K9958V90M)
Methylparaben (UNII: A2I8C7HI9T)
Mineral Oil (UNII: T5L8T28FGP)
Paraffin (UNII: I9O0E3H2ZE)
Petrolatum (UNII: 4T6H12BN9U)
Propylparaben (UNII: Z8IX2SC1OH)
Water (UNII: 059QF0KO0R)
White Wax (UNII: 7G1J5DA97F)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82652-027-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	06/01/2021

Part 4 of 13

TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

Product Information
Item Code (Source)	NDC:82652-028(NDC:47682-932)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	400 [USP'U] in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin	3.5 mg in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B	5000 [USP'U] in 1 g

Ingredient Name	Strength
Inactive Ingredients
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Saccharin Sodium (UNII: SB8ZUX40TY)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
FD&C Green No. 3 (UNII: 3P3ONR6O1S)
D&C Green No. 5 (UNII: 8J6RDU8L9X)
FD&C Red No. 3 (UNII: PN2ZH5LOQY)
D&C Red No. 28 (UNII: 767IP0Y5NH)
FD&C Red No. 40 (UNII: WZB9127XOA)
FD&C Yellow No. 5 (UNII: I753WB2F1M)
FD&C Yellow No. 6 (UNII: H77VEI93A8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82652-028-01	0.5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333B	06/04/2018

Part 5 of 13

ALCALAK
calcium carbonate tablet, chewable

Product Information
Item Code (Source)	NDC:82652-023(NDC:47682-201)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Calcium Carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	Calcium Carbonate	420 mg

Ingredient Name	Strength
Inactive Ingredients
Aspartame (UNII: Z0H242BBR1)
Croscarmellose Sodium (UNII: M28OL1HH48)
Acacia (UNII: 5C5403N26O)
Magnesium Stearate (UNII: 70097M6I30)
Maltodextrin (UNII: 7CVR7L4A2D)
Mineral Oil (UNII: T5L8T28FGP)
Sorbitol (UNII: 506T60A25R)
Sucrose (UNII: C151H8M554)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	AZ;036
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82652-023-01	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part331	06/15/2014

Part 6 of 13

I-PRIN
ibuprofen tablet, film coated

Product Information
Item Code (Source)	NDC:82652-024(NDC:47682-683)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM)	Ibuprofen	200 mg

Ingredient Name	Strength
Inactive Ingredients
Carnauba Wax (UNII: R12CBM0EIZ)
Starch, Corn (UNII: O8232NY3SJ)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Ferric Oxide Red (UNII: 1K09F3G675)
Lactose, Unspecified Form (UNII: J2B2A4N98G)
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Polydextrose (UNII: VH2XOU12IE)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
Polyvinyl Alcohol, Unspecified (UNII: 532B59J990)
Povidone K30 (UNII: U725QWY32X)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
Stearic Acid (UNII: 4ELV7Z65AP)
Talc (UNII: 7SEV7J4R1U)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;291
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82652-024-01	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075010	02/01/2021

Part 7 of 13

LORADAMED
loratadine tablet, film coated

Product Information
Item Code (Source)	NDC:82652-022(NDC:47682-203)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN)	Loratadine	10 mg

Ingredient Name	Strength
Inactive Ingredients
Starch, Corn (UNII: O8232NY3SJ)
Lactose Monohydrate (UNII: EWQ57Q8I5X)
Magnesium Stearate (UNII: 70097M6I30)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	RX;526
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82652-022-01	1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076134	12/30/2008

Part 8 of 13

COLD RELIEF
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet

Product Information
Item Code (Source)	NDC:82652-032(NDC:47682-725)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	15 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	200 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg

Ingredient Name	Strength
Inactive Ingredients
Maltodextrin (UNII: 7CVR7L4A2D)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Povidone, Unspecified (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
Stearic Acid (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR;12
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82652-032-01	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	02/01/2021

Part 9 of 13

DIPHEN
diphenhydramine hydrochloride tablet, film coated

Product Information
Item Code (Source)	NDC:82652-031(NDC:47682-166)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	25 mg

Ingredient Name	Strength
Inactive Ingredients
Carnauba Wax (UNII: R12CBM0EIZ)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Croscarmellose Sodium (UNII: M28OL1HH48)
D&C Red No. 27 (UNII: 2LRS185U6K)
Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Lactose, Unspecified Form (UNII: J2B2A4N98G)
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	048;D
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82652-031-01	1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	02/01/2021

Part 10 of 13

MEDI-LYTE
calcium carbonate, potassium chloride, and magnesium oxide tablet

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB, Carbonate Ion - UNII:7UJQ5OPE7D)	Calcium Carbonate	27 mg
Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)	Potassium Chloride	80 mg
Magnesium Oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	Magnesium Oxide	20 mg

Ingredient Name	Strength
Inactive Ingredients
Microcrystalline Cellulose (UNII: OP1R32D61U)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Stearic Acid (UNII: 4ELV7Z65AP)
Magnesium Stearate (UNII: 70097M6I30)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
DIETARY SUPPLEMENT		05/10/2022

Part 11 of 13

MEDI-MECLIZINE
meclizine hydrochloride tablet

Product Information
Item Code (Source)	NDC:82652-030(NDC:47682-481)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Meclizine Hydrochloride (UNII: HDP7W44CIO) (Meclizine - UNII:3L5TQ84570)	Meclizine Hydrochloride	25 mg

Ingredient Name	Strength
Inactive Ingredients
Anhydrous Lactose (UNII: 3SY5LH9PMK)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Starch, Corn (UNII: O8232NY3SJ)
D&C Yellow No. 10 (UNII: 35SW5USQ3G)
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	44;403
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82652-030-01	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part336	12/14/2020

Part 12 of 13

EXTRA STRENGTH APAP
acetaminophen tablet, film coated

Product Information
Item Code (Source)	NDC:82652-025(NDC:47682-043)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	500 mg

Ingredient Name	Strength
Inactive Ingredients
Starch, Corn (UNII: O8232NY3SJ)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Maltodextrin (UNII: 7CVR7L4A2D)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
Stearic Acid (UNII: 4ELV7Z65AP)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR;33
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82652-025-01	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	02/01/2021

Part 13 of 13

DIOTAME
bismuth subsalicylate tablet, chewable

Product Information
Item Code (Source)	NDC:82652-026(NDC:47682-210)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Bismuth Subsalicylate (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	Bismuth Subsalicylate	262 mg

Ingredient Name	Strength
Inactive Ingredients
Acacia (UNII: 5C5403N26O)
Aspartame (UNII: Z0H242BBR1)
Calcium Carbonate (UNII: H0G9379FGK)
D&C Red No. 27 (UNII: 2LRS185U6K)
Dextrates (UNII: G263MI44RU)
Magnesium Stearate (UNII: 70097M6I30)
Maltodextrin (UNII: 7CVR7L4A2D)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Silicon Dioxide (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	16mm
Flavor	PEPPERMINT	Imprint Code	RH;046
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82652-026-01	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part335	04/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076134	05/10/2022

Labeler - Remedy Pack LLC (101454060)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc		874965262	MANUFACTURE(82652-021)

Name	Address	ID/FEI	Business Operations
Establishment
Remedy Pack LLC		101454060	RELABEL(82652-033, 82652-029, 82652-027, 82652-028, 82652-023, 82652-024, 82652-022, 82652-032, 82652-031, 82652-030, 82652-025, 82652-026) , REPACK(82652-033, 82652-029, 82652-027, 82652-028, 82652-023, 82652-024, 82652-022, 82652-032, 82652-031, 82652-030, 82652-025, 82652-026)

Name	Address	ID/FEI	Business Operations
Establishment
Allegiant Health		079501930	MANUFACTURE(82652-021)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International Inc.		966812120	MANUFACTURE(82652-021)

Name	Address	ID/FEI	Business Operations
Establishment
Granules India Limited		918609236	MANUFACTURE(82652-021)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories		051565745	MANUFACTURE(82652-021)

View All Sections

	RxCUI	RxNorm NAME	RxTTY
1	198440	acetaminophen 500 MG Oral Tablet	PSN
2	198440	acetaminophen 500 MG Oral Tablet	SCD
3	198440	APAP 500 MG Oral Tablet	SY
4	204602	bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment	PSN
5	204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD
6	204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY
7	308761	bismuth subsalicylate 262 MG Chewable Tablet	PSN
8	308761	bismuth subsalicylate 262 MG Chewable Tablet	SCD
9	310965	ibuprofen 200 MG Oral Tablet	PSN
10	310965	ibuprofen 200 MG Oral Tablet	SCD
11	310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY
12	311372	loratadine 10 MG 24HR Oral Tablet	PSN
13	311372	loratadine 10 MG Oral Tablet	SCD
14	311372	loratadine 10 MG 24 HR Oral Tablet	SY
15	313884	calcium carbonate 420 MG (Ca 168 MG) Chewable Tablet	PSN
16	313884	calcium carbonate 420 MG Chewable Tablet	SCD
17	313884	calcium carbonate 420 MG (calcium 168 MG) Chewable Tablet	SY
18	995666	meclizine HCl 25 MG Oral Tablet	PSN
19	995666	meclizine hydrochloride 25 MG Oral Tablet	SCD
20	1012100	benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream	PSN
21	1012100	benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream	SCD
22	1012100	benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream	SY
23	1043690	hydrocortisone acetate 1 % Topical Cream	PSN
24	1043690	hydrocortisone acetate 10 MG/ML Topical Cream	SCD
25	1043690	hydrocortisone acetate 1 % Topical Cream	SY
26	1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN
27	1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD
28	1367204	acetaminophen 325 MG / dextromethorphan HBr 15 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet	PSN
29	1367204	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD
30	1367204	APAP 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY

	NDC
1	82652-021-01
2	82652-022-01
3	82652-023-01
4	82652-024-01
5	82652-025-01
6	82652-026-01
7	82652-027-01
8	82652-028-01
9	82652-029-01
10	82652-030-01
11	82652-031-01
12	82652-032-01
13	82652-033-01

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Active ingredients

Purpose

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Active Ingredient (in each gram)

Purposes

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Active Ingredient (in each gram)

Purpose

Active ingredients

Purpose

METHEMOGLOBINEMIA WARNING

ALLERGY ALERT

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Active ingredient (in each tablet)

Purpose

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Liver warning

Allergy alert

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Active ingredient (in each tablet)

Purpose

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When using this product

Active ingredient (in each tablet)

Purpose

Allergy alert

Stomach bleeding warning

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Active ingredient (in each tablet)

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Active ingredients

Purpose

Inactive Ingredients5

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Active ingredient (in each tablet)

Purpose

Liver warning

Allergy alert

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if

Stop using and ask a doctor if

Active ingredient (in each tablet)

Purpose

Stop use and ask a doctor if

OTHER INGREDIENTS

Active ingredient (in each tablet)

Purpose

Reye's syndrome

Allergy alert

Do not use if you have

Ask a doctor before use if you have

Ask a doctor or pharmacist if you are taking any drug for

Stop use and ask a doctor if

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Safety