Label: VALUE PHARMAPAIN RELIEVER EXTRA STRENGTH- aspirin tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 42787-102-12 - Packager: Ajes Pharmaceuticals,LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 May 25, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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
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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)
