ASPIRIN- aspirin tablet, coated
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 (enteric coated yellow)
USES
■ relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief
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
■ 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
Ask a doctor or pharmacist before use if you are
taking a prescription drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ arthritis
Stop use and ask a doctor if
■ 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
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 accidental overdose, contact a doctor or Poison Control Center immediately.
Directions
■ 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
| ASPIRIN
aspirin tablet, coated |
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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(62211-220) | |