aspirin tablet, coated
A&Z 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 you: ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDS (aspirin, ibuprofen, naproxen or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed
■ if you are allergic to aspirin or other pain relievers/fever reducers
■ stomach bleeding warning applies to you ■ you have history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis or kidney disease ■ you are taking a diuretic
■ you experience any of the following signs of stomach bleeding: feel faint, vomits blood, have bloody or black stools, have 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 ■ fever gets worse or lasts for more than 3 days ■ you may report side effects to 1-888-952-0050
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 accidental overdose, contact a doctor or Poison Control Center immediately.
■ drink a full glass of water with each does ■ adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor ■ Children under 12 years: consult a doctor
Anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow 10, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, titanium dioxide, triethyl citrate
aspirin tablet, coated
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|OTC monograph final||part343||11/03/2009|
|Labeler - A&Z Pharmaceutical, Inc. (926820705)|
|Registrant - A&Z Pharmaceutical, Inc. (926820705)|
|A&Z Pharmaceutical, Inc.||926820705||manufacture|