- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Do not use - if you have ever had an allergic reaction to any other pain relievers/fever reducers.
Reyes Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a rare but serious illness.
Allergy Alert: Aspirin may cause a sever allergic reaction which may include : facial swelling - asthma (wheezing) - shock - hives
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chances are higher if you are- 60 years of age or older - have had stomach ulcer bleeding problems - take a blood thinner (anticoagulant) or steroid drug - take other drugs containing prescription or non prescription NSAIDs (aspirin, ibuprofen, naproxen, others) - have 3 or more alcoholic drinks everyday while using this product - take more or for a longer time than directed
- DOSAGE & ADMINISTRATION
- NURSING MOTHERS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
VALUE PHARMAPAIN RELIEVER EXTRA STRENGTH
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42787-102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 325 mg in 325 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) talc (UNII: 7SEV7J4R1U) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color white (white color) Score no score Shape ROUND (Round Tablet) Size 11mm Flavor Imprint Code C10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42787-102-12 1 in 1 CARTON 1 325000 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(42787-102) , relabel(42787-102) , repack(42787-102)