Label: ADULT LOW DOSE ASPIRIN ENTERIC COATED- aspirin 81mg tablet, delayed release

  • 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 February 20, 2019

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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
    • facial swelling
    • asthma (wheezing)
    • 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 to aspirin or any other pain reliever/fever reducer
    • if you have ever had an allergic reaction to this 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 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
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • any new symptoms occur
    • ringing in the ears or 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.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center 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 at room temperature (15°-30°C)
    • avoid excess heat and moisture
    • Tamper Evident: do not use if safety seal under cap is broken or missing
  • Inactive ingredients

    croscarmellose sodium, D&C Yellow# 10 Lake, FD&C Yellow #6, hypromellose, lactose, methacrylic acid copolymer, microcrystalline cellulose, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, starch, talc, titanium dioxide, triacetin, triethyl citrate

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 16103-351-11

    Manufactured in the USA

    *Compare to the active ingredient in Bayer® Low Dose

    Adult Low Dose

    Aspirin

    ENTERIC COATED

    81mg

    Aspirin 81 mg

    Pain Reliever (NSAID)

    EA8

    1000 TABLETS

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

    Adult Low Dose Aspirin Enteric Coated Package Label

  • INGREDIENTS AND APPEARANCE
    ADULT LOW DOSE ASPIRIN ENTERIC COATED 
    aspirin 81mg tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-351
    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)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Coloryellow (YELLOW COLOR) Scoreno score
    ShapeROUND (ROUND TABLET) Size7mm
    FlavorImprint Code EA8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16103-351-09120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/20/2019
    2NDC:16103-351-16300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/20/2019
    3NDC:16103-351-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34302/20/2019
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(16103-351) , pack(16103-351) , analysis(16103-351) , label(16103-351)
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