Label: ASPIRIN LOW DOSE ENTERIC COATED- 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 17, 2018

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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

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

    *nonsteroidal anti-inflammatory drug


  • INACTIVE INGREDIENT

    anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, d&c yellow#10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, Polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

  • PURPOSE

    Uses • temporarily relieves minor aches and pains

    • for other uses, see your doctor, but do not use for more

    than 10 days without consulting your doctor because

    serious side effects may occur
  • DOSAGE & ADMINISTRATION

    Directions

    drink a full glass of water with each dose
    adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
    children under 12 years: consult a doctor

  • ASK DOCTOR

    Ask a doctor before use if • stomach bleeding warning

    applies to you • you have a history of stomach

    problems, such as heartburn • you have high blood

    pressure, heart disease, liver cirrhosis, or kidney disease

    • you are taking a diuretic • you have asthma • you

    have not been drinking fluids • you have lost a lot of

    fluid due to vomiting or diarrhea

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout, or arthritis

    • under a doctor’s care for any serious condition

    • taking any other drug

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout, or arthritis

    • under a doctor’s care for any serious condition

    • taking any other drug
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, 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.

    Keep out of reach of children. In case of overdose, get medical

    help or contact a Poison Control Center right away.
  • 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

    Uses

    temporarily relieves minor aches and pains
    for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

  • WARNINGS

    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:

    hives
    facial swelling
    shock
    asthma (wheezing)

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

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

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF BULK LABELEnter section text here

  • INGREDIENTS AND APPEARANCE
    ASPIRIN  LOW DOSE ENTERIC COATED
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-390
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code embossed;A;lower;plain
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-390-00100000 in 1 CARTON; Type 0: Not a Combination Product12/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34307/16/2010
    Labeler - Time-Cap Labs, Inc (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time-Cap Labs, Inc037052099manufacture(49483-390)
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