Active Ingredient
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflamatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Vitane Pharmaceuticals, Inc for the product Aspirin 81mg (NDC 60577-808). 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 ingredient, purpose, uses, warnings, allergy alert, other, do not use section, ask a doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflamatory drug
Pain reliever
Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
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:
Stomach Bleeding Warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Do not use if:
You are allergic to aspirin or any other pain reliever/fever reducer.
Ask a doctor or pharmacist before use if you are taking a prescription drug for
Stop use and ask a doctor if:
If pregnant or breast-feeding, ask a health professional.
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.
Directions:
Microcrystalline Cellulose, Talc, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Titanium Dioxide, Triethyl Citrate, Methacrylic Acid and Ethyl Acrylate Copolymer, D&C Yellow #10, FD&C Yellow #6
NDC 60577-808-01
Vitane's
Aspirin 81mg
Pain Reliever
Aspirin 81 mg (NSAID) Enteric Coated
60 tablets
* Please review the disclaimer below.