ASPIRIN
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aspirin tablet
A&Z Pharmaceutical, Inc.
*nonsteroidal anti-inflammatory drug
provides temporary relief of ■ headache■ pain and fever of colds ■ muscle pain ■ menstrual pain ■ toothache ■ minor pain of arthritis
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
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 reducer.
■ the stomach bleeding warning applies to you ■ you have history of stomach problems, such as heartburn ■ you have liver cirrhosis ■ you have asthma ■ you have high blood pressure ■ you have heart or kidney disease ■ you have taken a diuretic
■ taking any other drug containing an NSAID (prescription or nonprescription) ■ taking a blood thinning (anticoagulant) or steroid drug ■ taking a prescription drug for diabetes, gout or arthritis
■ you experience any of the following signs of stomach bleeding: ● feel faint ● vomit blood ● have bloody or black stools ● have stomach pain that does not get better ■ an allergic reaction occurs. Seek medical help right away. ■ pain gets worse or lasts for more than 10 days ■ redness or swelling is present ■ fever gets worse or lasts more than 3 days ■ any new symptoms occur ■ ringing in the ears or loss of hearing occurs
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.
■ drink a full glass of water with each does ■ adults: 1 to 2 tablets with water. Dosage may be repeated every 4 hours, not to exceed 12 tablets in 24 hours. ■ children under 12: consult a doctor.
ASPIRIN
aspirin tablet | ||||||||||||||||||
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part343 | 06/08/2022 |
Labeler - A&Z Pharmaceutical, Inc. (926820705) |
Registrant - A&Z Pharmaceutical, Inc. (926820705) |
Establishment | |||
Name | Address | ID/FEI | Operations |
A&Z Pharmaceutical, Inc. | 926820705 | manufacture |