Otc - Active Ingredient
ASPIRIN
The following Structured Product Label (SPL) was submitted to the FDA by Ajes Pharmaceuticals,llc for the product Value Pharma (NDC 42787-101). 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, inactive ingredient, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ASPIRIN
Purpose
Pain Reliever
Inactive Ingredients
In case of over dose get medical help and contact a Poison Control Center immediately.
For temporary relief of minor aches and pains or as recommended by your Doctor. Because of this products delayed release action, this product will not provide fast relief of headaches or symptoms needing immediate relief.
Do not use if you have ever had an allergic reaction to any other pain relievers/fever reducers. Children or teenagers who are recovering from the Chicken Pox or flu like symptoms should not use this product. When using this product if changes in behavior occur with nausea and vomiting occur,consult a Doctor because this could be a sign of Reye's Syndrome, a rare
but serious illness.
Directions - drink a full glass of water with each dose. Adults and children 12 years of age and over: take 4 to 8 tablets every 4 hours not to exceed48 tablets in 24 hours unless directed by a doctor. Children under 12 years: consult a doctor
* Please review the disclaimer below.