Label: ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER tablet, chewable

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

Drug Label Information

Updated March 17, 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 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 INGREDIENT

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

  • QUESTIONS

    1-800-616-2471

  • DOSAGE & ADMINISTRATION

    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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    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

  • PRINCIPAL DISPLAY PANEL

    BOTTLE LABEL

    RFID Label

  • INGREDIENTS AND APPEARANCE
    ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER 
    aspirin low dose chewable orange pain reliever tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51662-1356(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
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code PH034
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51662-1356-190 in 1 BOTTLE; Type 0: Not a Combination Product09/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/27/2018
    Labeler - HF Acquisition Co LLC, DBA HealthFirst (045657305)
    Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305)
    Establishment
    NameAddressID/FEIBusiness Operations
    HF Acquisition Co LLC, DBA HealthFirst045657305repack(51662-1356)