- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
WARNING:
Reye's Syndrome Warning: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s Syndrome, a rare but serious illness reported to be associated with aspirin.
Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours
• with other drugs containing acetaminophen (prescription or non-prescription)
• 3 or more alcoholic drinks every day while using this product.
Stomach Bleeding Warning: This product contains nonsteroidal antiinflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you: have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug
• are age 60 or older • have 3 or more alcoholic drinks every day while using this product • take with other drugs containing an NSAID • take more or for a longer time than directed.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN FREE PLUS
acetaminophen, aspirin, caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51532-0560 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code FR9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51532-0560-2 2 in 1 PACKET; Type 0: Not a Combination Product 10/25/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 10/25/2016 Labeler - Afassco Inc. (609982723) Registrant - ULTRAtab Laboratories, Inc. (151051757) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 manufacture(51532-0560) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 pack(51532-0560)