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Pill Identifier Information of ASA 81 MG Chewable Tablet

Drug Information

ASA 81 MG Chewable Tablet

Imprint: PH034
Shape: C48348
Color: C48331
Ingredients: Aspirin
Size: 8.00
Score: 1
Rxtty: SY
Author: Pharbest Pharmaceuticals, Inc.
Inactive Ingredients: DEXTROSE MONOHYDRATE / SILICON DIOXIDE / SACCHARIN SODIUM / FD&C YELLOW NO. 6 / STARCH, CORN / STEARIC ACID>

Complete Information

  • 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
    • 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

    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 mredical 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

    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: consult a doctor
  • Other information

    • Tamper Evident: Do not use if safety seal under cap is broken or missing
    • store at room temperature 20°-25°C (68°-77°F), excursions permitted between 15-30°C(59-86°F)
  • Inactive ingredients

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

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 16103-366-11

    Manufactured in the USA

    Aspirin Regimen

    Chewable

    Aspirin

    Low Dose

    81mg Pain Reliever (NSAID)

    *Compare 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 81mg low Dose Tablet Product Label.jpg

  • INGREDIENTS AND APPEARANCE
    LOW DOSE ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-366
    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:16103-366-051 in 1 CARTON08/22/2007
    136 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:16103-366-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/22/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/22/2007
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835analysis(16103-366) , manufacture(16103-366) , pack(16103-366) , label(16103-366)
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