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Aspirin

Rugby Laboratories Inc.
Advance Pharmaceutical Inc.

Children’s Aspirin (NSAID)




FULL PRESCRIBING INFORMATION

(in each tablet)

Aspirin 81 mg (NSAID)

*nonsteroidal anti-inflammatory drug

Pain Reliever

  • temporarily relieves minor aches and pains

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.

  • 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

store at room temperature 15°-30°C (59°-86°F)

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

Call 1-800-645-2158, 9am–5pm ET, Monday - Friday

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

Aspirin

NDC 0536-3297-36

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

Chewable Orange Flavor

36 Tablets

Rugby Duluth, Georgia 30097

Aspirin

Aspirin TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-3297
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 81 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
ORANGE
SILICON DIOXIDE
SUCROSE

Product Characteristics

Color Size Imprint Code Shape
YELLOW 8 mm AP;009 ROUND

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
part part343 1998-01-23


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Be sure to consult your doctor before taking any medication!
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