ASPIRIN EXTRA STRENGTH
ASPIRIN EXTRA STRENGTH 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 20181217.
Generic: ASPIRIN
Manufacturer: Time-Cap Labs, Inc
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 49483-382
Application: part343
Effective: 20181217
Active Ingredients: In each Tablet Asprin 500 mg (NSAID*) *non-steroidal anti-inflammatory drug
Indications & Usage
Use for the temporary relief of minor aches and pains due to: headache, colds, muscle pain, menstrual 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, asthmaaa9wheezing) 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, take other drugs containing prescription or nonprescription NSAIDs (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.
Adverse Reactions
Not available.