Label: ASPIRIN - aspirin tablet, chewable

  • NDC Code(s): 17714-009-36
  • Packager: Advance Pharmaceutical Inc.
  • 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 March 17, 2013

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

  • Active Ingredient

    (in each tablet)

    Aspirin 81 mg (NSAID) *

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain Reliever

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  • Use

    • temporarily relieves minor aches and pains
    • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effect may occur.
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  • 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 signs of  Reye’s syndrome, a rare but serious illness.

    Allergy Alert: Aspirin may cause a severe allergic reaction which may include

    • hives
    • asthma (wheezing)
    • shock
    • facial swelling

      Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child

    • has had stomach ulcers or bleeding problems
    • take a blood-thinning (anticoagulant) or steroid drug
    • takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
    • takes more or for a longer time than directed

      Do not use

    • if the child has ever had an allergic reaction to any other pain reliever / fever reducer
    • for at least 7 days after tonsillectomy or oral surgery

      Ask a doctor before use if

    • stomach bleeding warning applies to your child
    • child has a history of stomach problems, such as heartburn
    • child has not been drinking fluids
    • child has lost a lot of fluid due to vomiting and diarrhea
    • child has high blood pressure, heart disease, lever cirrhosis, or kidney disease
    • child is taking a diuretic
    • child has asthma

      Ask a doctor or pharmacist before use if the child is

    • taking a prescription drug for diabetes, gout or arthritis
    • taking any other drug
    • under a doctor’s care for any serious condition

      Stop use and ask a doctor if

    • child experiences any of the following signs of stomach bleeding:
    • feels faint
    • vomits blood
    • has bloody or black stools
    • has stomach pain that does not get better
    • pain gets worse or lasts more than 5 days
    • any new symptoms appear
    • redness or swelling is present in the painful area
    • ringing in the ears or a 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.

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  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • this product does not contain directions or complete warnings for adult use
    • administer only under adult supervision
    • if possible, use weight to dose, otherwise use age
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 doses in 24 hours
    • drink water with each dose
      Weight (lbs.) Age (years) Dose
      77 – 83 11 to under 12 4 – 6 tablets
      66 – 76 9 to under 11 4 - 5 tablets
      46 – 65 6 to under 9 4 tablets
      36 – 45 4 to under 6 3 tablets
      32 – 35 3 to under 4 2 tablets
      under 32 under 3 ask a doctor

      DRINK A FULL GLASS OF WATER WITH EACH DOSE

    • adults and children 12 years and older : take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours.
    • Children under 12 years: ask a doctor
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  • Other Information

    • store at 15-30 °C (59-86 °F)
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  • Inactive Ingredients

    corn starch, FD&C Yellow #6 alum. lake, magnesium stearate, orange flavor, silicon dioxide, sugar

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  • Questions or Comments

    Call 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    655159bb-figure-01
    655159bb-figure-02

    NDC: 17714-009-36 – 36 COUNT

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:17714-009
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ORANGE (UNII: 5EVU04N5QU)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color ORANGE Score score with uneven pieces
    Shape ROUND Size 8mm
    Flavor ORANGE Imprint Code AP;009
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17714-009-36 36 in 1 BOTTLE
    1 1 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 04/15/1988
    Labeler - Advance Pharmaceutical Inc. (078301063)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    Name Address ID/FEI Business Operations
    Advance Pharmaceutical Inc. 078301063 MANUFACTURE(17714-009)
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