Label: CHEWABLE ASPIRIN LOW DOSE- chewable aspirin 81mg tablet, chewable

  • 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 July 22, 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 recommneded by your doctor
    • ask your doctor about other uses for Chewable Aspirin 81 mg
  • 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
    • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
    • if you have 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 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 stools
    • 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
    • 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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • 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 exceed 48 tablets in 24 hours unless directed by a doctor
     children under 12 years ask a doctor

  • Other information

    • store at 20-250C (68-770F)
    • avoid excess heat and moisture
  • Inactive ingredients

    corn starch, dextrose monohydrate, FD&C yellow #6, orange flavor, silicon dioxide, sodium saccharine, stearic acid

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 73057-366-11

    Manufactured in the USA

    ASPIRIN REGIMEN

    Chewable 

    Aspirin

    Low Dose

    81mg Pain Reliever (NSAID)

    *Comapre to the active ingredient in BAYER® Chewable Aspirin

    Orange Flavored

    1000 TABLETS

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

    Chewable Aspirin 81 mg Tablet Product Label

  • INGREDIENTS AND APPEARANCE
    CHEWABLE ASPIRIN LOW DOSE 
    chewable aspirin 81mg tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73057-366
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize8mm
    FlavorORANGEImprint Code PH034
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73057-366-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/2019
    2NDC:73057-366-0536 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34306/28/2019
    Labeler - Ulai Health LLC (081181535)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
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