Active Ingredients
Each tablet contains Aspirin 325 mg (NSAID)
Aspirin Tablet, Coated
FDA Label NDC 49483-011
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 49483-011). 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, inactive ingredients, purpose, dosage and administration, indications and usage, warnings, keep out of the reach of children, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Corn Starch, Croscramellose Sodium, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Titanium Dioxide
Purpose
Pain Reliever
Dosage And Administration
Drink a full glass of water with each doses
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.
Indications And Usage
For the temporary relief of aches and pains due to:
headache, colds,menstral pain, muscle pain, toothache,minor pain of arthritis or as directed by your doctor
Warnings
Reyes'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 reactin, which may include hives, facial swelling, shock, asthma (wheezing)
Stomach bleeding warning: This produc tcontains 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 non prescription 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.
Keep Out Of The Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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