Label: ASPIRIN tablet, coated

  • 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 April 17, 2011

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  • Drug Facts

    Active ingredient (in each tablet)

    Aspirin (NSAID*) .............................. 81 mg

    *Nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain Reliever

  • Uses

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

  • Warnings

    Reye's 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 and 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 severe allergic reaction which may include:

    • facial swelling
    • asthma (wheezing)
    • shock
    • hives

    Alcohol Warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

    Do not use if you have ever had an allergic reaction to any other pain relievers/fever reducers.

    Ask a doctor before use if you have

    • stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
    • bleeding problems
    • ulcers
    • asthma

    Ask a doctor or pharmacist before use if you are taking a prescription drug for

    • diabetes
    • gout
    • arthritis
    • anticoagulation ( thinning of blood)

    Indicated for pain relief.

    Stop use and ask a doctor if

    • An allergic reaction occurs. Seek medical help right away
    • Pain gets worse or lasts more than 10 days
    • Redness or swelling is present
    • New symptoms occur
    • Ringing in the ears or loss of hearing occurs.

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

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center immediately.

  • 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 exceed 48 tablets in 24 hours unless directed by doctor.
    • Children under 12 years: consult a doctor
  • Other Information

    • Store at room temperature
  • Inactive Ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C Yellow # 10 al lake, FD&C Yellow # 6 al lake, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl citrate

  • QUESTIONS

    Questions or Comments?
    Call 1-866-383-9908

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Cispharma Inc
    1212 Cranbury S River Road
    Cranbury, NJ 08512

  • PRINCIPAL DISPLAY PANEL

    ASPIRIN ENTERIC COATED YELLOW TABLETS, 81 mg, Bulk
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52204-103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorYELLOW (YELLOW) Scoreno score
    ShapeROUND (Round) Size6mm
    FlavorImprint Code C;3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52204-103-99166667 in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34302/14/2011
    Labeler - Cispharma, Inc (833171445)
    Registrant - Cispharma, Inc (833171445)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cispharma, Inc833171445manufacture
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