Label: LOW DOSE ASPIRIN- aspirin tablet, coated

  • NDC Code(s): 70677-1150-1, 70677-1150-2, 70677-1150-3
  • Packager: Strategic Sourcing Services LLC
  • 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 May 24, 2023

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  • Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug 

  • Purpose

    Pain reliever 

  • 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
  • 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.
    • if you have ever had an allergic reaction to his product or any of its ingredients

    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

    • 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
    • fever get worse or lasts more than 3 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 at during the last 3 month 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 (1-800-222-1222) right away. 

  • 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
  • Other information

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

    croscarmellose sodium, D&C yellow #10, lactose monohydrate, methacrylic acid, microcrystalline cellulose 102, polacrilin potassium, polyethylene glycol 6000, polyvinyl alcohol, purified talc, silicon dioxide, sodium lauryl sulfate, soybean, titanium dioxide, triethyl citrate

  • Questions or comments?

    Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm  EST 

  • Principal Display Panel

    COMPARE TO BAYER® LOW DOSE ASPIRIN ACTIVE INGREDIENT†

    LOW DOSE

    Aspirin 81 mg

    PAIN RELIEVER (NSAID)

    Aspirin regimen±

    Enteric coated±±

    Safety coated±±

    TABLETS

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

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

    ≠≠Coating helps protect against stomach upset

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by: McKesson Corp.,

    via Strategic Sourcing Services LLC. Memphis, TN 38141

    www.fosterand thrive.com

  • Product Label

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

    FOSTER & THRIVE Low Dose Aspirin

  • INGREDIENTS AND APPEARANCE
    LOW DOSE ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1150
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-1150-21 in 1 BOX04/01/2023
    1180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:70677-1150-31 in 1 BOX04/01/2023
    2300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:70677-1150-11 in 1 BOX04/01/2023
    3120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34304/01/2023
    Labeler - Strategic Sourcing Services LLC (116956644)
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