Label: ASPIRIN LOW DOSE- aspirin tablet

  • NDC Code(s): 49638-001-01, 49638-001-02
  • Packager: America Medic
  • 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

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

  • ACTIVE INGREDIENT


    Aspirin
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  • PURPOSE

    Internal Analgesic.
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  • 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.

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  • INDICATIONS & USAGE

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

    Yellow # 10

    Yellow # 6

    Methacrylic Acid Copolymer

    Microcrystalline Cellose

    Stearic Acid

    Titanium Dioxide

    Triethyl Citrate

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  • PRINCIPAL DISPLAY PANEL

    Image of cartonImage of carton

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN  LOW DOSE
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49638-001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color yellow (yellow ) Score no score
    Shape ROUND (tablet) Size 6mm
    Flavor Imprint Code C3
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49638-001-02 1 in 1 CARTON
    1 NDC:49638-001-01 120 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 05/15/2012
    Labeler - America Medic (071065464)
    Establishment
    Name Address ID/FEI Business Operations
    America Medic 071065464 relabel, repack
    Establishment
    Name Address ID/FEI Business Operations
    Cispharma Inc. 833171445 manufacture
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