Label: VALUE PHARMA ASPIRIN PAIN RELIEVER- aspirin tablet

  • NDC Code(s): 42787-101-50
  • Packager: Ajes Pharmaceuticals,LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ASPIRIN

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  • INACTIVE INGREDIENT

     Inactive Ingredients

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  • KEEP OUT OF REACH OF CHILDREN

    In case of over dose get medical help and contact a Poison Control Center immediately.

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  • INDICATIONS & USAGE

    For temporary relief of minor aches and pains or as recommended by your Doctor. Because of this products delayed release action, this product will not provide fast relief of headaches or symptoms needing immediate relief.

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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.

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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 4 to 8 tablets every 4 hours not to exceed48 tablets in 24 hours unless directed by a doctor. Children under 12 years: consult a doctor

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  • PURPOSE

    Purpose

    Pain Reliever

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  • INGREDIENTS AND APPEARANCE
    VALUE PHARMA  ASPIRIN PAIN RELIEVER
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42787-101
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aspirin (Aspirin) Aspirin 81 mg  in 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    Silicon Dioxide  
    Croscarmellose Sodium  
    CELLULOSE, MICROCRYSTALLINE  
    CELLULOSE, MICROCRYSTALLINE  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
    CELLULOSE, MICROCRYSTALLINE  
    Stearic Acid  
    talc  
    Titanium Dioxide  
    Triethyl Citrate  
    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
    1 4050 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(42787-101)
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