Label: MEDS ON THE GO- acetaminophen, calcium carbonate, dextromethorphan hbr, guaifenesin, phenylephrine hcl, ibuprofen, loperamide hcl kit
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Contains inactivated NDC Code(s)
NDC Code(s): 47682-126-99, 47682-139-99, 47682-200-46, 47682-708-99, view more47682-820-99, 72082-002-05 - Packager: Doc in the Box LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated January 1, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- EXTRA STRENGTH NON-ASPIRIN
- EXTRA STRENGTH NON-ASPIRIN
- EXTRA STRENGTH NON-ASPIRIN
-
EXTRA STRENGTH NON-ASPIRIN
Warnings
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.
- EXTRA STRENGTH NON-ASPIRIN
- EXTRA STRENGTH NON-ASPIRIN
- EXTRA STRENGTH NON-ASPIRIN
- EXTRA STRENGTH NON-ASPIRIN
- EXTRA STRENGTH NON-ASPIRIN
- EXTRA STRENGTH NON-ASPIRIN
-
EXTRA STRENGH NON-ASPIRIN
Directions
- do not use more than directed
Adults and children:
(12 years and older)
Take 2 tablets with water 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.
- EXTRA STRENGTH NON-ASPIRIN
- EXTRA STRENGTH NON-ASPIRIN
- EXTRA STRENGTH NON-ASPIRIN
- ANTACID
- ANTACID
- ANTACID
- ANTACID
- ANTACID
- ANTACID
- ANTACID
- ANTACID
-
ANTACID
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 take more than 19 tablets in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.
- Children under 12 years: Do not give to children under 12 years of age.
- ANTACID
- ANTACID
- ANTACID
- COLD RELIEF
- COLD RELIEF
- COLD RELIEF
-
COLD RELIEF
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg 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.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
-
COLD RELIEF
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 its 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.
- COLD RELIEF
- COLD RELIEF
- COLD RELIEF
-
COLD RELIEF
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.
- COLD RELIEF
- COLD RELIEF
- COLD RELIEF
- COLD RELIEF
- COLD RELIEF
- COLD RELIEF
- IBUPROFEN
- IBUPROFEN
- IBUPROFEN
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IBUPROFEN
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- skin reddening
- asthma (wheezing)
- facial swelling
- rash
- shock
- blisters
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
- taking 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
- IBUPROFEN
-
IBUPROFEN
Ask a doctor before use if
- 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, or kidney disease
- you are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have asthma
- IBUPROFEN
- IBUPROFEN
-
IBUPROFEN
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- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling is present in the painful area
- any new or unexpected symptoms occur
- IBUPROFEN
- IBUPROFEN
-
IBUPROFEN
Directions
- do not use 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 for 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. - IBUPROFEN
-
IBUPROFEN
Inactive ingredients
carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone (K-30)*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide
* may contain
- IBUPROFEN
- DIAMODE
- DIAMODE
- DIAMODE
- DIAMODE
- DIAMODE
- DIAMODE
- DIAMODE
- DIAMODE
- DIAMODE
- DIAMODE
- DIAMODE
-
DIAMODE
Directions
- do not use more than directed
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Adults and children:
(12 years and older)
Take 2 caplets after the first loose stool
followed by 1 caplet after each subsequent
loose stool but no more than 4 caplets in 24 hours.
Children under 12 years: Do not give to children under 12 years of age. - DIAMODE
- DIAMODE
- DIAMODE
- EXTRA STRENGTH NON-ASPIRIN
- ANTACID
- COLD RELIEF
- IBUPROFEN
- DIAMODE
- OUTER CARTON PDP
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INGREDIENTS AND APPEARANCE
MEDS ON THE GO
acetaminophen, calcium carbonate, dextromethorphan hbr, guaifenesin, phenylephrine hcl, ibuprofen, loperamide hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72082-002 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72082-002-05 1 in 1 BOX; Type 1: Convenience Kit of Co-Package 01/01/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 PACKET 3 in 2 Part 2 2 PACKET 4 in 2 Part 3 2 PACKET 3 in 2 Part 4 2 PACKET 3 in 2 Part 5 4 PACKET 4 Part 1 of 5 MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH
acetaminophen tablet, film coatedProduct Information Item Code (Source) NDC:47682-126 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 SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSES (UNII: 3NXW29V3WO) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color white (white) Score no score Shape ROUND (Round) Size 12mm Flavor Imprint Code FR;33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-126-99 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 01/01/2019 Part 2 of 5 MEDI-FIRST ANTACID
calcium carbonate tablet, chewableProduct Information Item Code (Source) NDC:47682-820 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 MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCROSE (UNII: C151H8M554) ASPARTAME (UNII: Z0H242BBR1) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ACACIA (UNII: 5C5403N26O) MAGNESIUM STEARATE (UNII: 70097M6I30) MINERAL OIL (UNII: T5L8T28FGP) SORBITOL (UNII: 506T60A25R) 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:47682-820-99 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 01/01/2019 Part 3 of 5 MEDI-FIRST COLD RELIEF
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tabletProduct Information Item Code (Source) NDC:47682-139 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (white) Score no score Shape ROUND (round) Size 12mm Flavor Imprint Code FR;12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-139-99 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 01/01/2019 Part 4 of 5 MEDI-FIRST IBUPROFEN
ibuprofen tablet, coatedProduct Information Item Code (Source) NDC:47682-708 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 TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color red (Reddish Brown) Score no score Shape ROUND Size 10mm Flavor Imprint Code G;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-708-99 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 ANDA079174 01/01/2019 Part 5 of 5 MEDIQUE DIAMODE
loperamide hydrochloride tabletProduct Information Item Code (Source) NDC:47682-200 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 2 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CROSPOVIDONE (UNII: 2S7830E561) CORN OIL (UNII: 8470G57WFM) POWDERED CELLULOSE (UNII: SMD1X3XO9M) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color green Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 123 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-200-46 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 ANDA074091 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2019 Labeler - Doc in the Box LLC (081033259) Establishment Name Address ID/FEI Business Operations Doc in the Box LLC 081033259 repack(72082-002)