Quality Plus 44-157
Drug Labeling and Warnings
Drug Details [pdf]
ASPIRIN THIN COATED- aspirin tablet
Major Pharmaceuticals
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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Quality Plus 44-157
Uses
temporary relieves:
- minor pain of arthritis
- headache
- muscle pain
- toothache
- menstrual pain
- pain and fever of colds
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 more or for a longer time than directed
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription and nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
Ask a doctor before use if
- the stomach bleeding warning applies to you
- you have liver cirrhosis
- you have a history of stomach problems, such as heartburn
- you have heart or kidney disease
- you are taking a diuretic
- you have high blood pressure
- you have asthma
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- gout
- diabetes
- arthiritis
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 more than 10 days
- redness or swelling is present
- any new symptoms occur
- fever gets worse or lasts more than 3 days
- ringing in the ears or loss of hearing occurs
Directions
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 to 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours.
- children under 12 years: consult a doctor
Other information
- use by expiration date on package
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Principal display panel
MAJOR PHARMACEUTICALS
NDC: 0904-2019-59
†Compare to the active ingredient in Genuine Bayer® Aspirin
Aspirin
325 mg
Pain reliever/
Fever reducer (NSAID)
100 Tablets
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Bayer® HealthCare LLC, owner of the registered trademark Genuine Bayer® Aspirin.
50844 ORG091315712
| ASPIRIN
THIN COATED
aspirin tablet |
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| Labeler - Major Pharmaceuticals (191427277) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | MANUFACTURE(0904-2019) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 967626305 | PACK(0904-2019) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | PACK(0904-2019) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 868734088 | PACK(0904-2019) | |