Label: 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
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NDC Code(s):
82652-021-01,
82652-022-01,
82652-023-01,
82652-024-01, view more82652-025-01, 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
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 11, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- INGREDIENTS
- USES
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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
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- SPL UNCLASSIFIED SECTION
- INGREDIENTS
- USES
- WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- SPL UNCLASSIFIED SECTION
- INGREDIENTS
- USES
- WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- SPL UNCLASSIFIED SECTION
- INGREDIENTS
- USES
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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
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- SPL UNCLASSIFIED SECTION
- INGREDIENTS
- INACTIVE INGREDIENTS1
- USES
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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.
- DIRECTIONS
- OTHER INFORMATION
- SPL UNCLASSIFIED SECTION
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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*
- USES
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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
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.
- DIRECTIONS
- OTHER INFORMATION
- SPL UNCLASSIFIED SECTION
- INGREDIENTS
- INACTIVE INGREDIENTS*
- USES
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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
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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
- SPL UNCLASSIFIED SECTION
- INGREDIENTS
- INACTIVE INGREDIENTS3
- USES
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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
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- -
- feel faint
- -
- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
- you have symptoms of heart problems or stroke
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- 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
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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
- SPL UNCLASSIFIED SECTION
- INGREDIENTS
- INACTIVE INGREDIENTS4
- USES
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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
- DIRECTIONS
- OTHER INFORMATION
- SPL UNCLASSIFIED SECTION
- INGREDIENTS
- INACTIVE INGREDIENTS6
- USES
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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
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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
- SPL UNCLASSIFIED SECTION
- INGREDIENTS
- INACTIVE INGREDIENTS*
- USES
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WARNING
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.
- DIRECTIONS
- OTHER INFORMATION
- SPL UNCLASSIFIED SECTION
- INFORMATION
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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
- DIRECTIONS
- OTHER INFORMATION
- SPL UNCLASSIFIED SECTION
- INGREDIENTS
- INACTIVE INGREDIENTS*
- USES
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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
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
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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
- PRINCIPAL DISPLAY PANEL - Kit Carton
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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 kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82652-021 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82652-021-01 1 in 1 CARTON 05/10/2022 Quantity of Parts Part # Package Quantity Total Product Quantity 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 liquidProduct Information Item Code (Source) NDC:82652-033(NDC:61010-8100) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine 200 mg in 1 g Inactive Ingredients Ingredient Name Strength polyethylene glycol 400 (UNII: B697894SGQ) polyethylene glycol 3350 (UNII: G2M7P15E5P) peppermint oil (UNII: AV092KU4JH) saccharin sodium (UNII: SB8ZUX40TY) sorbic acid (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82652-033-01 0.75 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/01/2010 Part 2 of 13 BURN
benzalkonium chloride and lidocaine hydrochloride creamProduct Information Item Code (Source) NDC:82652-029(NDC:47682-940) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82652-029-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 08/29/2017 Part 3 of 13 HYDROCORTISONE
hydrocortisone creamProduct Information Item Code (Source) NDC:82652-027(NDC:47682-923) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82652-027-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 06/01/2021 Part 4 of 13 TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointmentProduct Information Item Code (Source) NDC:82652-028(NDC:47682-932) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82652-028-01 0.5 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333B 06/04/2018 Part 5 of 13 ALCALAK
calcium carbonate tablet, chewableProduct Information Item Code (Source) NDC:82652-023(NDC:47682-201) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Calcium Carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) Calcium Carbonate 420 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82652-023-01 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part331 06/15/2014 Part 6 of 13 I-PRIN
ibuprofen tablet, film coatedProduct Information Item Code (Source) NDC:82652-024(NDC:47682-683) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen 200 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82652-024-01 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075010 02/01/2021 Part 7 of 13 LORADAMED
loratadine tablet, film coatedProduct Information Item Code (Source) NDC:82652-022(NDC:47682-203) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine 10 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82652-022-01 1 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076134 12/30/2008 Part 8 of 13 COLD RELIEF
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tabletProduct Information Item Code (Source) NDC:82652-032(NDC:47682-725) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82652-032-01 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 02/01/2021 Part 9 of 13 DIPHEN
diphenhydramine hydrochloride tablet, film coatedProduct Information Item Code (Source) NDC:82652-031(NDC:47682-166) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 25 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82652-031-01 1 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 02/01/2021 Part 10 of 13 MEDI-LYTE
calcium carbonate, potassium chloride, and magnesium oxide tabletProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 05/10/2022 Part 11 of 13 MEDI-MECLIZINE
meclizine hydrochloride tabletProduct Information Item Code (Source) NDC:82652-030(NDC:47682-481) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Meclizine Hydrochloride (UNII: HDP7W44CIO) (Meclizine - UNII:3L5TQ84570) Meclizine Hydrochloride 25 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82652-030-01 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part336 12/14/2020 Part 12 of 13 EXTRA STRENGTH APAP
acetaminophen tablet, film coatedProduct Information Item Code (Source) NDC:82652-025(NDC:47682-043) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 500 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82652-025-01 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 02/01/2021 Part 13 of 13 DIOTAME
bismuth subsalicylate tablet, chewableProduct Information Item Code (Source) NDC:82652-026(NDC:47682-210) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bismuth Subsalicylate (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) Bismuth Subsalicylate 262 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82652-026-01 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part335 04/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076134 05/10/2022 Labeler - Remedy Pack LLC (101454060) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc 874965262 MANUFACTURE(82652-021) Establishment Name Address ID/FEI Business Operations 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) Establishment Name Address ID/FEI Business Operations Allegiant Health 079501930 MANUFACTURE(82652-021) Establishment Name Address ID/FEI Business Operations LNK International Inc. 966812120 MANUFACTURE(82652-021) Establishment Name Address ID/FEI Business Operations Granules India Limited 918609236 MANUFACTURE(82652-021) Establishment Name Address ID/FEI Business Operations Ohm Laboratories 051565745 MANUFACTURE(82652-021)
