ASPIRIN- aspirin tablet
Winder Laboratories, LLC
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
For the temporary relief of minor aches and pains associated with:
- a cold
- headache
- toothache
- muscular aches
- backache
- premenstrual and menstrual cramps
- minor pain from arthritis
- and to reduce fever
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 a nonsteroidal anti-inflammatory drug (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 a prescription or nonprescription NSAID (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
Do not use
- If you have ever had an allergic reaction to any other pain reliever/fever reducer
- if you are allergic to aspirin
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis or kidney disease
- you are taking a diuretic
- you have asthma
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- anticoagulation (thinning of the blood)
- diabetes
- gout
- 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
- pain gets worse or lasts for more than 10 days
- fever persists or lasts for more than 3 days
- ringing in the ears or loss of hearing occurs
These could be signs of a serious condition.
Directions
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 or 2 tablets with water every 4 hours while symptoms persist. Not more than 12 tablets in 24 hours.
- children under 12 years: consult a doctor
| ASPIRIN
aspirin tablet |
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| Labeler - Winder Laboratories, LLC (965195170) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Winder Laboratories, LLC | 965195170 | manufacture(75826-104) , analysis(75826-104) | |