Otc - Active Ingredient
Active Ingredient (in each tablet)
Aspirin 81 mg (NSAID)*
*Nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Aarna Usa Inc. for the product Aspirin Low Dose (NDC 82568-0003). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient (in each tablet)
Aspirin 81 mg (NSAID)*
*Nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
temporarily relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relieve of headache or symptoms 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 the symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Asiprin may cause a severe allergic reaction, which may include:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. Ths chance is higher if you:
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are
Stop use and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
adults and children 12 years and over:
children under 12 years: ask a doctor
Other information
Inactive ingredients:
colloidal silicon dioxide, crospovidone, D&C yellow #10 lake, hydroxypropyl methyl cellulose,methacrylic acid copolymer,microcrystalline cellulose, starch maize,starch pregelatinized, stearic acid, talc, titanium dioxide
Questions or comments? Call toll-free 1-877-225-6999
Monday to Friday 9AM to 5PM
*This product is not manufactured or distributed by Bayer Health Care LLC., owner of the registered Bayer® Low Dose Aspirin.
Manufactured for:
Aarna USA Inc.
Leland, NC 28451
* Please review the disclaimer below.