Label: PAIN RELIEVER / LOW DOSE ASPIRIN- aspirin tablet, chewable

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

Drug Label Information

Updated June 27, 2024

If you are a consumer or patient please visit this version.

  • 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 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 alergic 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 alergic to aspirin or any other pain reliever/fever reducer
    • this product for at least 7 days after tonsilectomy 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 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
    • allergic reaction occurs
    • pain gets worse or lasts more than 10 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 (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 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 the safety seal under the cap is broken or missing
    • Store at room temperature (15°-30°C) 59ºF- 86ºF
    • Avoid excess heat and moisture
  • Inactive ingredients

    Corn starch, dextrose monohydrate, FD&C yelow #6, flavor, silicon dioxide, sodium saccharine and stearic acid.

  • Questions or comments?

    Adverse drug event call: (866) 562-2756 (Mon-Fri 8AM to 4PM EST)

  • Package Label Principal Display Panel

    PHARMAMED

    NDC 84289-366-36

    Manufactured in the U.S.A

    Pain Reliever (NSAID) / Low Dose

    ASPIRIN

    Aspirin 81 mg

    36 CHEWABLE

    Aspirin regimen

    Orange Flavored

    *Compare to the active ingredient in BAYER Chewable Aspirin

    Label Image

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER / LOW DOSE ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84289-366(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
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize8mm
    FlavorORANGEImprint Code PH034
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84289-366-3636 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2024
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)10/01/2024
    Labeler - PHARMAMED USA INC (065607328)
    Registrant - PHARBEST PHARMACEUTICALS, INC. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHARBEST PHARMACEUTICALS, INC.557054835repack(84289-366)