Label: ASPIR LOW- aspirin tablet

  • 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 22, 2020

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

  • Active ingredient

    Aspirin 81 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

  • 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 right away.

  • 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

  • Warnings

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

    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 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

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

    ■ 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

    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.

  • 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

  • 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

  • Questions?

    Adverse Drug Event Call: (800) 616-2471

  • 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 BAYER® Low Dose

    **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 NEWWARNINGS INFORMATION

    NEWTablet Appearance

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    MAJOR®

  • Package/Label Principal Display Panel

    PDP

  • INGREDIENTS AND APPEARANCE
    ASPIR LOW 
    aspirin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66267-028(NDC:0904-7704)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    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)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code HEART
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66267-028-3030 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2016
    2NDC:66267-028-9090 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2016
    3NDC:66267-028-00100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2016
    4NDC:66267-028-91120 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34305/24/2011
    Labeler - NuCare Pharmaceuticals, Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals, Inc.010632300repack(66267-028)