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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Drug Facts
Uses
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- temporarily relieves minor aches and pains due to:
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- headache
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- minor arthritis pain
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- toothache
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- menstrual pain
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- colds
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- or as recommended by a doctor
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:
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- hives
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- shock
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- facial swelling
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- asthma (wheezing)
Stomach bleeding warning
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- have 3 or more alcoholic drinks every day while using this product
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- take more or for a longer time than directed
Do Not Use
if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
Ask Doctor before use if
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- stomach bleeding warning applies to you
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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- you are taking a diuretic
- •
- you have asthma
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- •
- diabetes
- •
- gout
- •
- arthritis
- •
- an allergic reaction occurs. Seek medical help right away.
- •
- you experience any of the following signs of stomach bleeding:
- o
- feel faint
- o
- vomit blood
- o
- have bloody or black stools
- o
- have stomach pain that does not get better
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- pain gets worse or lasts more than 10 days
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- redness or swelling is present
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- any new symptoms occur
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- ringing in the ears or a loss of hearing occurs. These could be signs of a serious condition.
Keep Out of Reach of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
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- adults and children 12 years of age and over: take 1 or 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose
- •
- do not take more than 12 tablets in 24 hours unless directed by a doctor
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- children under 12 years: ask a doctor.
| 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 | LABEL(62211-839) , PACK(62211-839) , RELABEL(62211-839) , REPACK(62211-839) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Anshi Pharmaceutical (Zhongshan) Inc. | 528101821 | MANUFACTURE(62211-839) , ANALYSIS(62211-839) , LABEL(62211-839) , PACK(62211-839) | |