Aspirin by Qualitest Pharmaceutical, Inc.
Dosage form: tablet
Ingredients: ASPIRIN 81mg
Labeler: Qualitest Pharmaceutical, Inc.
NDC Code: 0603-0024
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.
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
■ temporarily relieves minor aches and pains due to the common cold, sore throat, headache, and toothache ■ temporarily reduces fever
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.
Allergy alert: Aspirin may cause a severe allergic reaction which may include hives, facial swelling, asthma (wheezing), shock. If allergy reaction occurs, stop use and seek medical help right away.
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
taking a prescription drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ arthritis
■ 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|
store at room temperature
You may report serious side effects to 1-888-952-0050
Dextrates, FD&C yellow #6, flavor, saccharin sodium, starch
|Labeler - Qualitest Pharmaceutical, Inc. (011103059)|
|Registrant - A&Z Pharmaceutical, Inc. (926820705)|
|A&Z Pharmaceutical, Inc.||926820705||manufacture|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.