Label: ASPIRIN - aspirin tablet, delayed release

  • NDC Code(s): 11534-155-11
  • Packager: Sunrise Pharmaceutical Inc
  • 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 10, 2011

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

  • OTC - ACTIVE INGREDIENT

    Aspirin 81 mg (NSAID) nonsteroidal anti-inflammatory drug

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  • OTC - PURPOSE

    Pain reliever.

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  • INDICATIONS AND USAGE

    For 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.

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  • 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, asthma (wheezing), shock.

    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.

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  • OTC - ASK 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.

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  • OTC - ASK DOCTOR/PHARMACIST

    Before use if you are taking a prescription drug for:

    gout

    diabetes

    arthritis

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  • OTC - 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,

    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.

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  • OTC - PREGNANCY 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.

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  • OTC - 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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  • DOSAGE AND ADMINISTRATION

    Drink with 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

    OTHER INFORMATION

    Store at 15°-30°C (59°-86°F). Do not use if imprinted seal under cap is missing or damaged.

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  • INACTIVE INGREDIENT

    Anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide, triethyl citrate.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, delayed release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11534-155
    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
    LACTOSE (UNII: J2B2A4N98G)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code heart
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11534-155-11 120 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 01/03/2010
    Labeler - Sunrise Pharmaceutical Inc (168522378)
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