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

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.

NDC 0536-3297-36

Children’s Aspirin (NSAID) 1^1/4 gr (81 mg)
Pain Reliever

Chewable Orange Flavor

36 Tablets

Rugby Duluth, Georgia 30097