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 Cispharma, Inc. 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.
Drug Facts
Active ingredient (in each tablet)
Aspirin (NSAID*) .............................. 325 mg
Uses
For the temporary relief of minor aches and pains due to headache, minor arthritis, colds, muscle pain, toothache, menstrual pain, or as recommended by your 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:
- facial swelling
- asthma (wheezing)
- shock
- hives
Alcohol Warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.
Directions:
- Do not take more than directed
- Adults and children 12 years of age and over: take 1 to 2 tablets every 4 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
- Children under 12 years: consult a doctor
Other Information
- Store below 25°C
Inactive Ingredients
colloidal silicon dioxide, FD&C Yellow # 6 al lake, hypromellose, methacrylic acid copolymer, starch, talc, titanium dioxide, triacetin, triethyl citrate
* Please review the disclaimer below.