Label: VALUE PHARMA ASPIRIN PAIN RELIEVER- aspirin tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 42787-101-50 - Packager: Ajes Pharmaceuticals,LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 20, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
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.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VALUE PHARMA ASPIRIN PAIN RELIEVER
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42787-101 Route of Administration ORAL 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) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) 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 10/01/2012 1 4050 mg in 1 BOTTLE; Type 0: Not a Combination Product 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)