Your browser does not support JavaScript! VALUE PHARMA ASPIRIN PAIN RELIEVER (ASPIRIN) TABLET [AJES PHARMACEUTICALS,LLC]
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VALUE PHARMA ASPIRIN PAIN RELIEVER (aspirin) tablet
[Ajes Pharmaceuticals,LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

ASPIRIN

 Inactive Ingredients

In case of over dose get medical help and contact a Poison Control Center immediately.

For temporary relief of minor aches and pains or as recommended by your Doctor. Because of this products delayed release action, this product will not provide fast relief of headaches or symptoms needing immediate relief.

Do not use if you have ever had an allergic reaction to any other pain relievers/fever reducers. Children or teenagers who are recovering from the Chicken Pox or flu like symptoms should not use this product. When using this product if changes in behavior occur with nausea and vomiting occur,consult a Doctor because this could be a sign of Reye's Syndrome, a rare
 but serious illness.

Directions - drink a full glass of water with each dose. Adults and children 12 years of age and over: take 4 to 8 tablets every 4 hours not to exceed48 tablets in 24 hours unless directed by a doctor. Children under 12 years: consult a doctor

copy of label

Purpose

Pain Reliever

VALUE PHARMA  ASPIRIN PAIN RELIEVER
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42787-101
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aspirin (Aspirin) Aspirin81 mg  in 81 mg
Inactive Ingredients
Ingredient NameStrength
Silicon Dioxide 
Croscarmellose Sodium 
CELLULOSE, MICROCRYSTALLINE 
CELLULOSE, MICROCRYSTALLINE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
CELLULOSE, MICROCRYSTALLINE 
Stearic Acid 
talc 
Titanium Dioxide 
Triethyl Citrate 
Product Characteristics
Coloryellow (Yellow color) Scoreno score
ShapeROUND (Round Pill) Size6mm
FlavorImprint Code C3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42787-101-501 in 1 CARTON
14050 mg in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34310/01/2012
Labeler - Ajes Pharmaceuticals,LLC (159945393)
Establishment
NameAddressID/FEIBusiness Operations
Ajes Pharmaceuticals,LLC159945393manufacture(42787-101)

Revised: 9/2012
 
Ajes Pharmaceuticals,LLC

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