Label: ASPIRIN- aspirin tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

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

  • ACTIVE INGREDIENTS (IN EACH TABLET)

    Aspirin 81mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

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  • PURPOSE

    Pain reliever

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  • USES

    for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed 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 very serious illness.

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

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

    if an allergic reaction occurs, stop use and seek medical help right away.

    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

    if you are allergic to aspirin or other pain relievers/fever reducers

    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 have asthma
    • you are taking a diuretic

    Ask a doctor or pharmacist before use if you are

    Taking a prescription drug for:

    • anticoagulation (thinning of the blood)
    • diabetes
    • gout
    • 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
    • new symptoms occur
    • redness or swelling is present
    • Ringing in the ears or loss of hearing occurs
    • Pain gets worse or lasts for more than 10 days

    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 specifically 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.

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  • 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
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  • OTHER INFORMATION

    • store at room temperature
    • do not use if imprinted safety seal under cap is broken or missing

    You may report side effects to: 1-888-952-0050.

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  • 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 laurel sulfate, talc, titanium dioxide, triethyl citrate

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  • PRINCIPAL DISPLAY PANEL

    Pain Reliever

    Delayed-Release Enteric Coated

    Bottle of 120 - 68788-9671-1

    Aspirin 81mg Delayed-Release Enteric Coated
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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68788-9671(NDC:0603-0026)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (ASPIRIN) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    ANHYDROUS LACTOSE  
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    D&C YELLOW NO. 10  
    POLYSORBATE 80  
    SODIUM HYDROXIDE  
    TALC  
    TITANIUM DIOXIDE  
    TRIETHYL CITRATE  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
    DIMETHICONE  
    FERRIC OXIDE RED  
    Product Characteristics
    Color yellow Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68788-9671-1 120 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 06/06/2013
    Labeler - Preferred Pharmaceuticals, Inc. (791119022)
    Establishment
    Name Address ID/FEI Business Operations
    Preferred Pharmaceuticals, Inc. 791119022 REPACK(68788-9671)
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