Label: LOW DOSE ASPIRIN- aspirin tablet, coated

  • 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 April 26, 2018

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

  • Active ingredient (in each tablet)

    Aspirin 81 mg (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.
    • ask your doctor about other uses for safety coated 81 mg aspirin
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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
    • 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

    if you are allergic to aspirin or any 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 have asthma
    • you are taking a diuretic 

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for

    • gout
    • diabetes
    • 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 stool
      • have stomach pain that does not get better
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present 
    • ringing in the ears or loss of hearing occurs
    • new symptoms occur

    These could be signs of a serious condition

    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 (1-800-222-1222).

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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: do not use
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  • Other information

    • store between 15-30ºC (59-86ºF)
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  • Inactive ingredients

    anhydrous lactose**, black iron oxide**, brown iron oxide**, corn starch**, croscarmellose sodium**, D&C yellow #10, FD&C yellow #6**, hypromellose**, methacrylic acid copolymer, microcrystalline cellulose, mineral oil**, pharmaceutical ink**, polysorbate 80**,  potassium hydroxide**, propylene glycol**, purified water**, shellac**, silicon dioxide, simethicone**, sodium bicarbonate**, sodium hydroxide**, sodium lauryl sulfate**, stearic acid**, talc, titanium dioxide, triethyl citrate, yellow iron oxide**

    **contains one or more of these ingredients 

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  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

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  • Principal Display Panel

    Compare to the active ingredient in Bayer® Low Dose Aspirin

    Aspirin 81 mg

    Low Dose

    Pain reliever (NSAID)

    Aspirin regimen±

    Enteric Coated±±

    Safety coated

    This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Bayer® Low Dose Aspirin.

    ≠≠Coating helps protect against stomach upset

    Talk to your doctor or other healthcare provider before using this product for your heart.Aspirin is not right for everyone.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Distributed by:

    Major® Pharmaceuticals

    17177 N Laurel Park Drive,

    Suite, Livonia MI 48152

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  • Product Label

    Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug

    MAJOR Aspirin 81 mg Low Dose

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  • INGREDIENTS AND APPEARANCE
    LOW DOSE ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6713
    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)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code E;T81;1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-6713-18 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/28/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 02/28/2018
    Labeler - Major Pharmaceuticals (191427277)
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