ASPIRIN- aspirin tablet
A&Z Pharmaceutical, Inc.
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.
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Aspirin
USES
provides temporary relief of ■ headache■ pain and fever of colds ■ muscle pain ■ menstrual pain ■ toothache ■ minor pain of arthritis
WARNINGS
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
Ask a doctor before use if
■ 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
Ask a doctor or pharmacist before use if you are
■ 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
Stop use and ask a doctor if
■ 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
If pregnant or breast-feeding,
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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
| ASPIRIN
aspirin tablet |
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| Labeler - A&Z Pharmaceutical, Inc. (926820705) |
| Registrant - A&Z Pharmaceutical, Inc. (926820705) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| A&Z Pharmaceutical, Inc. | 926820705 | manufacture(62211-312) | |