ASPIRIN
ASPIRIN is an FDA drug label for the active ingredient ASPIRIN manufactured by TIME CAP LABS INC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231122.
Generic: ASPIRIN
Manufacturer: TIME CAP LABS INC
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 49483-011
Application: M013
Effective: 20231122
Active Ingredients: Active ingredient (in each tablet) Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug
Indications & Usage
INDICATIONS AND USAGE Uses for the temporary relief of minor aches and pains due to headache colds menstrual pain muscle pain toothache minor pain of arthritis or as directed by your doctor
Dosage & Administration
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: consult a doctor
Contraindications
Not available.
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: hives facial swelling shock asthma (wheezing) Stomach bleeding warning: This product contains an 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 have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
Adverse Reactions
Not available.