GRIPMAX- acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide tablet 
Unipharm, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Gripmax Tablets

Relieves major cold and flu-like symptoms

  • Nasal decongestant
  • Fever reducer
  • Muscle and joint pain relieve
  • Cough suppressant
  • Relieves headache
  • Relieves sore throat pain

ACTIVE INGREDIENT

Active IngredientsOne Tablet
Acetaminophen325 mg
Dextromethorphan HBr10.5 mg
Pseudoephedrine HCl25 mg

Other Ingredients

Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, Silicon Dioxide, Stearic Acid.

INDICATIONS

For the temporary relief of cold and flu-like symptoms.

Directions: adults and children 12 y/o take 1-2 tablets no more than 4 times daily. Do not take tablets less than 4 hours apart. Use for only 3-5 days.

WARNINGS

Do not use during pregnancy or breastfeeding

Non prescription.

Storage: store at room temperatures 15°-30°C.

Keep out of reach of children.

Manufacturer:

Contract Pharmacal Corp.

135 Adam Avenue, Hauppauge, NY 11788

for Unipharm, Inc.

350 Fifth Ave., NY, NY 10118

Phone 1-212-594-3260

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8fbf2be8-figure-01
GRIPMAX 
acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62900-4012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE25 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10.5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE K30 (UNII: U725QWY32X)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (white to off white with yellow spots) Scoreno score
ShapeROUND (round, flat shaped compressed tablet with beveled edges) Size12mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62900-4012-212 in 1 BLISTER PACK; Type 0: Not a Combination Product06/01/201403/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/01/201403/24/2020
Labeler - Unipharm, Inc. (884789132)
Registrant - Unipharm, Inc. (884789132)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp968335112MANUFACTURE(62900-4012)

Revised: 3/2020
Document Id: a025c0e7-2924-41a4-8899-727223513dbe
Set id: 3c2c6020-445a-4b4f-a9ee-3cdaddb19ff1
Version: 3
Effective Time: 20200324
 
Unipharm, Inc.