Label: ASPIRIN LOW DOSE CHEWABLE ORANGE- aspirin tablet, chewable

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

Drug Label Information

Updated March 11, 2024

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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
    • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

    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

    • 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
    • ringing in the ears or loss of hearing occurs
    • any new symptoms occur

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

  • Other information

    • store at room temperature (150-300C)
    • Tamper Evident: do not use if safety seal under cap is broken or missing
  • Inactive ingredients

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

  • Questions or comments?

    1-800-616-2471

  • HOW SUPPLIED

    Product: 50090-7028

    NDC: 50090-7028-0 1 TABLET, CHEWABLE in a BLISTER PACK / 36 in a CARTON

  • Aspirin

    Label Image
  • INGREDIENTS AND APPEARANCE
    ASPIRIN LOW DOSE CHEWABLE ORANGE 
    aspirin tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-7028(NDC:0904-6794)
    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)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code PH034
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-7028-036 in 1 CARTON01/08/2024
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/27/2018
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-7028)
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