Label: ADULT LOW DOSE ENTERIC COATED ASPIRIN- aspirin tablet, coated

  • Category: HUMAN OTC DRUG LABEL

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 August 22, 2012

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  • Active ingredient (in each tablet)

    Aspirin 81 mg(NSAID)* *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

  • Uses

    • for the temporary relief of minor aches and pains
    • ask your doctor about other uses for aspirin
  • Warnings

    This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ask a health professional before use. it is especially important not to use aspirin during the 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.

    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. Reye's Syndrome:

    Aspirin may cause a severe allergic reaction which may include: Allergy Alert:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
    Stomach bleeding warning:
    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    if your are allergic to aspirin or any other pain reliever/fever reducer. Do not use

    Ask a doctor before use if

    • the stomach bleeding warning applies to you
    • you are taking a diuretic
    • you have a history of stomach problems, such as heartburn
    • you have: -high blood pressure -heart disease -liver cirrhosis  -kidney disease -asthma

    Ask a doctor or pharmacist before use if you are

    • taking any other drug containing an NSAID (prescription or nonprescription)
    • taking a blood thinning (anticoagulant) or steroid drug
    • taking a prescription drug for diabetes, gout or arthritis

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding: -feel faint -vomit blood -have bloody or black stools -have stomach pain that does not get better
    • an allergic reaction occurs. Seek medical help right away
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • fever gets worse or lasts more than 3 days
    • any new symptoms occur
    • ringing in the ears or loss of hearing occurs
    If pregnant or breast-feeding,

    In case of overdose , get medical help or contact a Poison Control Center right away. Keep out of reach of children.

  • Directions

    • drink a full glass of water with each dose
    • swallow whole, do not chew or crush
    • do not exceed recommended dose
    • adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
    • children under 12 years: ask a doctor
  • Other information

    • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
    • for institutional use only
  • Inactive ingredients

    cellulose, D and C yellow #10, FD and C yellow #6, hypromellose, iron oxide, PEG, polydextrose, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax. May also contain: acetylated monoglycerides, croscarmellose sodium, hypromellose, phthalate, lactose, methacrylic acid, mineral oil, polysorbate 80, sodium lauryl sulfate.

  • ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED

    Label Image
  • INGREDIENTS AND APPEARANCE
    ADULT LOW DOSE ENTERIC COATED ASPIRIN  
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64725-0981(NDC:50844-600)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64725-0981-1100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34307/01/2000
    Labeler - TYA Pharmaceuticals (938389038)
    Registrant - TYA Pharmaceuticals (938389038)
    Establishment
    NameAddressID/FEIBusiness Operations
    TYA Pharmaceuticals938389038RELABEL(64725-0981) , REPACK(64725-0981)