FDA Label for Aspirin
View Indications, Usage & Precautions
Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product United Exchange Corp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (in each tablet) Purpose
Aspirin 325 mg (NSAID)*....................................Pain reliever/fever reducer
*nonsteroidal anti-inflammatory drug
Otc - Purpose
Uses
temporarily relieves minor aches and pains due to:
- headache
- muscual aches
- minor pain of arthritis
- backache
- the common cold
- toothache
- premenstrual and menstrual cramps
Warnings
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:
- facial swelling
- shock
- hives
- asthma (wheezing)
- are age 60 or older
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have had stomach ulcers or bleeding problems
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Otc - Do Not Use
Do not use if you are allergic to aspirin or any other pain reliever/fever reducer
Otc - Ask Doctor
Ask a doctor before use if
- you have asthma
- 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
- gout
- diabetes
- arhiritis
Ask a doctor or pharmacist before use if you are taking a prescription drug for
Otc - Stop Use
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloddy or black stools
- have stomach pain that does not get better
- an allergic reaction occurs. Seek medical help right away.
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
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 definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
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 while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor.
- children under 12 years: do not use unless directed by a doctor
Storage And Handling
Other information
- use by expiration date on package
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredient
Inactive ingredient corn starch
Dosage & Administration
Distributed by:
United Exchange Corp.
17211 Valley View Ave.
Cerritos, CA 90703
Made in USA
Package Label.Principal Display Panel
* Please review the disclaimer below.