Label: ADULT LOW DOSE ASPIRIN ENTERIC SAFETY COATED- aspirin tablet, delayed release

  • 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 January 18, 2011

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

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)                   Purpose
    Aspirin 81 mg (NSAID*)................................Pain reliever
    *nonsteroidal anti-inflammatory drug

  • INDICATIONS & USAGE

    Uses
    • for the temporarily relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.
    • ask your doctor about other uses of this product
  • 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
    • 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
  • DO NOT USE

    Do not use
    • if you are allergic to aspirin or any other pain reliever/fever reducer
  • 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
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are
    • taking a prescription drug for:
    • gout, or arthritis
  • STOP USE

    Stop use and ask a doctor if:
    • an allergic reaction occurs, Seek medical help right away.
    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • have bloody or black stools
      • vomit blood
      • have stomach pain that does not get better
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • ringing in the ears or a loss of hearing occurs
    These could be signs of a serious condition.
  • 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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • 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; do not exceed 48 tablets in 24 hours unless directed by a doctor
    • children under 12 years: consult a doctor
  • STORAGE AND HANDLING

    • store between 20° - 25°C (60° - 77°F) in a dry place
  • INACTIVE INGREDIENT

    Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow # 10, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF BOTTLE LABEL
  • INGREDIENTS AND APPEARANCE
    ADULT LOW DOSE ASPIRIN  ENTERIC SAFETY COATED
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75942-001
    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)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    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;upper;8;lower;plain
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75942-001-12120 in 1 BOTTLE, PLASTIC
    2NDC:75942-001-36360 in 1 BOTTLE, PLASTIC
    3NDC:75942-001-50500 in 1 BOTTLE, PLASTIC
    4NDC:75942-001-75750 in 1 BOTTLE, PLASTIC
    5NDC:75942-001-101000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34301/18/2011
    Labeler - Zandi LLC (784431590)