Label: ASPIRIN LOW DOSE- 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 May 16, 2012

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  • ACTIVE INGREDIENT


    Aspirin
  • PURPOSE

    Internal Analgesic.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose get medical help or contact a poison control center right away.

  • INDICATIONS & USAGE

    Oral Analgesic. Aspirin is not appropriate for everyone, so be sure to talk to a doctor before starting an Aspirin regimen.
  • WARNINGS


    Do not use this product if you are allergic to Aspirin or any other pain/fever product.
    If pregnant or breastfeeding contact a doctor before using.
    Contact a doctor or pharmacist if you are taking a prescription drug for-Gout, Diabetes or Arthritis.
    Contact a doctor right away if: An allergic reaction occurs.
  • DOSAGE & ADMINISTRATION


    Drink a full glass of water with each dose.
    Adults and children 12 years of age and up:Take 4-8 tablets every 4 hours not to exceed 48 tablets in 24hours unless indicated by a doctor.. Children under 12 years of age : Consult a Doctor.
  • INACTIVE INGREDIENT

    Yellow # 10

    Yellow # 6

    Methacrylic Acid Copolymer

    Microcrystalline Cellose

    Stearic Acid

    Titanium Dioxide

    Triethyl Citrate

  • PRINCIPAL DISPLAY PANEL

    Image of cartonImage of carton

  • INGREDIENTS AND APPEARANCE
    ASPIRIN  LOW DOSE
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49638-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Coloryellow (yellow ) Scoreno score
    ShapeROUND (tablet) Size6mm
    FlavorImprint Code C3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49638-001-021 in 1 CARTON
    1NDC:49638-001-01120 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34305/15/2012
    Labeler - America Medic (071065464)
    Establishment
    NameAddressID/FEIBusiness Operations
    America Medic071065464relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Cispharma Inc.833171445manufacture
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