Qualitest Pharmaceutical, Inc.
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.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user ■ has had stomach ulcers or bleeding problems ■ takes a blood thinning (anticoagulant) or steroid drug ■ takes other drugs containing prescription or nonprescription NSAIDS (aspirin, ibuprofen, naproxen or others) ■ takes more or for a longer time than directed ■ is age 60 or older ■ has 3 or more alcoholic drinks everyday while using this product
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.
■ if you are allergic to aspirin or other pain relievers/fever reducers ■ for at least 7 days after tonsillectomy or oral surgery
■ stomach bleeding warning applies to user ■ user has history of stomach problems, such as heartburn ■ user has high blood pressure, heart disease, liver cirrhosis or kidney disease ■ user has asthma ■ user takes a diuretic ■ user has not been drinking fluids ■ user has lost a lot of fluids due to vomiting or diarrhea
■ user 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 ■ new symptoms occur ■ redness or swelling is present ■ ringing in the ears or loss of hearing occurs ■ pain gets worse or lasts for more than 10 days (for adults) or 5 days (for children) ■ fever gets worse or lasts for more than 3 days
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery
In case of overdose, get medical help or contact a Poison Control Center right away.
■ to be administered only under adult supervision ■ if possible use weight to dose, otherwise use age ■ repeat every 4 hours, while symptoms persist, up to a maximum of five doses in 24 hours or as directed by a doctor ■ drink a full glass of water with each does
|Age (yrs)||Weight (lbs)||Dosage|
|under 3||under 32||consult a doctor|
|3 to under 4||32 to 35||2 tablets|
|4 to under 6||36 to 45||3 tablets|
|6 to under 9||46 to 65||4 tablets|
|9 to under 11||66 to 76||4 to 5 tablets|
|11 to under 12||77 to 83||4 to 6 tablets|
|Adults and children 12 years and over||5 to 8 tablets|
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|OTC monograph final||part343||11/03/2009|
|Labeler - Qualitest Pharmaceutical, Inc. (011103059)|
|Registrant - A&Z Pharmaceutical, Inc. (926820705)|
|A&Z Pharmaceutical, Inc.||926820705||manufacture|