Label: ASPIRIN ENTERIC COATED- aspirin 81 mg tablet

  • NDC Code(s): 69168-318-01, 69168-318-03
  • Packager: Allegiant Health
  • 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 November 7, 2018

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

  • Active ingredient

    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 pain 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 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 non presecription 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 reliever/fever reducer

    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 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

    • an allergic reaction occurs. Seek medical help right away.

    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
    • 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
    • You may report serious side effects to 1-888-952-0050

    Pregnancy/Breastfeeding

    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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 of age: consult a doctor
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  • Other information

    • save carton for full directions and warnings
    • store at room temperature
    • do not use if imprinted safety seal under cap is broken or missing
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  • Inactive ingredients

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

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  • Principal Display Panel

    Bio Formula

    ASPIRIN

    (NSAID*)

    81mg SAFETY COATED

    ENTERIC COATED

    LOW STRENGTH ASPIRIN REGIMEN

    DELAYED RELEASE ASPIRIN

    Bio Formula Aspirin 81mg Carton 100ct

    Bio Formula Aspirin 81mg Carton 100ct

    Bio Formula Aspirin 81mg Label 100ct

    Bio Formula Aspirin 81mg Label 100ct

    Bio Formula Aspirin 81mg Label 300ct

    Bio Formula Aspirin 81mg Label 300ct

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN  ENTERIC COATED
    aspirin 81 mg tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-318
    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
    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)  
    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)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    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:69168-318-01 1 in 1 CARTON 12/18/2014
    1 100 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:69168-318-03 300 in 1 BOTTLE; Type 0: Not a Combination Product 12/18/2014
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 12/18/2014
    Labeler - Allegiant Health (079501930)
    Registrant - Allegiant Health (079501930)
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