Label: VALUE PHARMA ASPIRIN PAIN RELIEVER- aspirin tablet

  • 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 December 20, 2018

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  • ACTIVE INGREDIENT

    ASPIRIN

  • PURPOSE

    Purpose

    Pain Reliever

  • INACTIVE INGREDIENT

    Inactive Ingredients

  • KEEP OUT OF REACH OF CHILDREN

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

  • 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.

  • 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.

  • 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

  • PRINCIPAL DISPLAY PANEL

    copy of label
  • INGREDIENTS AND APPEARANCE
    VALUE PHARMA   ASPIRIN PAIN RELIEVER
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42787-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg  in 81 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Coloryellow (Yellow color) Scoreno score
    ShapeROUND (Round Pill) Size6mm
    FlavorImprint Code C3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42787-101-501 in 1 CARTON10/01/2012
    14050 mg in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34310/01/2012
    Labeler - Ajes Pharmaceuticals,LLC (159945393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ajes Pharmaceuticals,LLC159945393manufacture(42787-101)
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