Label: VALUE PHARMA ASPIRIN PAIN RELIEVER- aspirin tablet
- NDC Code(s): 42787-101-50
- Packager: Ajes Pharmaceuticals,LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated September 5, 2012
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
In case of over dose get medical help and contact a Poison Control Center immediately.Close
- INDICATIONS & USAGE
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.Close
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 rareClose
but serious illness.
- DOSAGE & ADMINISTRATION
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 doctorClose
- INGREDIENTS AND APPEARANCE
VALUE PHARMA ASPIRIN PAIN RELIEVER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42787-101 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 81 mg in 81 mg Inactive Ingredients Ingredient Name Strength Silicon Dioxide (UNII: ETJ7Z6XBU4) Croscarmellose Sodium (UNII: M28OL1HH48) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Stearic Acid (UNII: 4ELV7Z65AP) talc (UNII: 7SEV7J4R1U) Titanium Dioxide (UNII: 15FIX9V2JP) Triethyl Citrate (UNII: 8Z96QXD6UM) Product Characteristics Color yellow (Yellow color) Score no score Shape ROUND (Round Pill) Size 6mm Flavor Imprint Code C3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42787-101-50 1 in 1 CARTON 1 4050 mg in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 10/01/2012 Labeler - Ajes Pharmaceuticals,LLC (159945393) Establishment Name Address ID/FEI Business Operations Ajes Pharmaceuticals,LLC 159945393 manufacture(42787-101)