Label: ASPIR LOW- 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 08/12

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

  • Active ingredient

    Aspirin 81 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever

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  • Keep Out of Reach of Children

    In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

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  • Uses

    ■ temporarily relieves minor aches and pains

    ■ for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

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  • Warnings

    Children and teenagers who have or are recovering from chicken pox or flulike Reyeʼs syndrome:

    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.

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

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

    This product contains an NSAID, which may cause severe stomach Stomach bleeding warning:

    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

    ■ if you are allergic to aspirin or any other pain reliever/fever reducer Do not use

    ■ stomach bleeding warning applies to you Ask a doctor before use if

    ■ 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

    ■ you have not been drinking fluids ■ you have lost a lot of fluid due to vomiting or diarrhea

    Ask a doctor or pharmacist before use if you are

    ■ taking a prescription drug for diabetes, gout, or arthritis

    ■ under a doctor’s care for any serious condition ■ taking any other drug

    ■ you experience any of the following signs of stomach bleeding: Stop use and ask a doctor if

    ■ 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

    , ask a health professional before use. It is especially important not If pregnant or breast-feeding

    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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  • 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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  • Inactive ingredients

    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 sulfate, talc, titanium dioxide, triethyl citrate

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  • Questions?

    Adverse Drug Event Call: (800) 616-2471

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  • Other Information

    ■ store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

    ■ use by expiration date on package

    **Compare to the active ingredient in Low Dose BAYER®

    **This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered

    trademark Bayer® Low Dose.

    Distributed by

    Major Pharmaceuticals

    31778 Enterprise Drive,

    Livonia, MI 48150 USA

      ASPIR LOW™

    LOW STRENGTH 81mg ASPIRIN (NSAID)

    Enteric Coated

    1 1/4 gr. (81 mg) each Analgesic

    SEE NEWWARNINGSINFORMATION

    NEWTabletAppearance

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    MAJOR®

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  • ASPIR LOW (ASPIRIN) TABLET
  • INGREDIENTS AND APPEARANCE
    ASPIR LOW 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50436-0127(NDC:0904-7704)
    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
    ANHYDROUS LACTOSE  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    D&C YELLOW NO. 10  
    FERRIC OXIDE YELLOW  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
    CELLULOSE, MICROCRYSTALLINE  
    POLYSORBATE 80  
    DIMETHICONE  
    SODIUM HYDROXIDE  
    SODIUM LAURYL SULFATE  
    TALC  
    TITANIUM DIOXIDE  
    TRIETHYL CITRATE  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50436-0127-1 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 05/24/2011
    Labeler - Unit Dose Services (831995316)
    Registrant - Unit Dose Services (831995316)
    Establishment
    Name Address ID/FEI Business Operations
    Unit Dose Services 831995316 REPACK(50436-0127)
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