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 America Medic & Science, Llc. 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.
Aspirin Delayed Release Tablets, Usp 81 Mglow Dosesafety Coated Aspirin
Drug Facts
Active Ingredient
Aspirin 81 mg (NSAID)**
**nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
- for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headaches or other sypmtoms needing immediate relief.
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
Otc - Ask Doctor/Pharmacist
Ask your doctor or pharmacist before use if you are taking a prescription drug for
- gout
- diabetes
- arthritis
Directions
- drink a full glass of water with each dose
- adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
- children under 12 years: consult a doctor.
Other Information
- save carton for full directions and warnings
- store at room temperature
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C Yellow # 10 al lake, FD&C Yellow # 6 al lake, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl citrate
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