Label: ADULT LOW DOSE ASPIRIN- aspirin tablet, delayed release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 24, 2025

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  • Active ingredient (in each tablet)

    Aspirin 81mg (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 headache or other symptoms needing immediate relief)
    • ask your doctor about other uses for this product
  • 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
    • asthma (wheezing)
    • facial swelling
    • 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 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 reaction to aspirin or any other pain reliever/fever reducer

    Ask a doctor before use if

    • the 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

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

    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 (800-222-1222).

  • 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: ask a doctor
  • Other information

    • Tamper Evident: Do not use if safetyseal under cap is broken or missing
    • store at 20°-25°C (68-77°F), excursions permitted between 15-30°C(59-86°F)
    • avoid excess heat and moisture
  • Inactive ingredients

    croscarmellose sodium, D&C yellow# 10, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide.

  • Questions or comments?

    (866) 562-2756 Mon-Fri 8 AM to 4 PM EST

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 16103-356-09

    Manufactured in the U.S.A

    Low Dose

    Aspirin

    Pain Reliever (NSAID)

    †COMPARE to the active ingredient in BAYER®LOW DOSE

    Aspirin Regimen 81 mg each

    120 ENTERIC COATED TABLETS

    Talk to your doctor  or other healthcare provider before using this product for your heart.

    Aspirin 81mg Enteric coated Tablet Product Label.jpg

  • INGREDIENTS AND APPEARANCE
    ADULT LOW DOSE ASPIRIN 
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-356
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Coloryellow (YELLOW COLOR) Scoreno score
    ShapeROUND (ROUND TABLET) Size8mm
    FlavorImprint Code PH023
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16103-356-091 in 1 CARTON01/12/2007
    1120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:16103-356-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01/12/2007
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835analysis(16103-356) , manufacture(16103-356) , pack(16103-356) , label(16103-356)
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