Label: ASPIRIN - aspirin tablet

  • NDC Code(s): 0536-3297-36
  • Packager: Rugby Laboratories 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 December 10, 2012

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
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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

      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
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  • Other Information

    store at room temperature 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 1-800-645-2158, 9am–5pm ET, Monday - Friday

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

    C:\Users\advance\Desktop\word docs - rugby\children aspirin 81 mg\Figure 1.png

    NDC 0536-3297-36

    Children’s Aspirin (NSAID) 11/4 gr (81 mg)
    Pain Reliever

    Chewable Orange Flavor

    36 Tablets

    Rugby Duluth, Georgia 30097

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3297
    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 YELLOW Score no score
    Shape ROUND Size 8mm
    Flavor ORANGE Imprint Code AP;009
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-3297-36 36 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 01/23/1998
    Labeler - Rugby Laboratories Inc. (191427277)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    Name Address ID/FEI Business Operations
    Advance Pharmaceutical Inc. 078301063 MANUFACTURE(0536-3297)
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