Label: VALUE PHARMAPAIN RELIEVER EXTRA STRENGTH- aspirin tablet

  • NDC Code(s): 42787-102-50
  • 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 November 15, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)

    Aspirin 325 mg (NSAID)*

    nonsteroidal antiinflammatory drug

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  • INACTIVE INGREDIENT

    Inactive Ingredients Hydroxypropylmethyl cellulose, polyethylene glycol, starch, talc, titanium dioxide

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  • PURPOSE

    Purpose

    Pain reliever /  Fever reducer

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

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  • INDICATIONS & USAGE

    Uses provides temporary relief of: headache pain and fever of colds - muscle pain - toothache - minor pain of arthritis

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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

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  • DOSAGE & ADMINISTRATION

    Directions - drink a full glass of water with each dose - Adults and children 12 years of age and over: take 1 to 2 tablets with water. Dosage may be repeated every 4 hours, not to exceed 12 tablets in 24 hours. Children under 12: consult a doctor

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  • NURSING MOTHERS

    If pregnant or breast-feeding ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn or complications during delivery

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  • INGREDIENTS AND APPEARANCE
    VALUE PHARMAPAIN RELIEVER  EXTRA STRENGTH
    aspirin tablet
    Product 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:42787-102-50 1 in 1 CARTON
    1 16250 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)
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