Active Ingredients
Drug Facts
Active ingredient (in each tablet) Purpose
Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever
*nonsteroidal anti-inflammatory drug
Aspirin Tablet, Chewable
FDA Label NDC 49483-334
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Time-cap Labs, Inc for the product Aspirin (NDC 49483-334). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, otc - keep out of reach of children, inactive ingredient, otc - purpose, indications & usage, dosage & administration, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 right away.
Inactive Ingredient
Inactive ingredients: bht, dextrates, FD-C yellow #6 aluminum Lake, microcrystalline cellulose, modified corn starch, orange flavor, pregelatinized starch, sodium saccharin, stearic acid
Otc - Purpose
PURPOSE: Pain reliever
Indications & Usage
Uses • temporarily relieves minor aches and pains
• for other uses, see your doctor, but do not use for more
than 10 days without consulting your doctor because
serious side effects may occur
Dosage & Administration
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
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 serous
Illinois.
Allergy alert: Aspirin may cause a severe allergic reaction, which may include: facial swelling, shock, hives, 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, 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, tae more or for a longer time than directed..
Package Label.Principal Display Panel
334label (334bottle)
* Please review the disclaimer below.
