Otc - Active Ingredient
Active Ingredient (in each tablet)
Aspirin 325 mg (NSAID)*
nonsteroidal antiinflammatory drug
Value Pharmapain Reliever
FDA Label NDC 42787-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ajes Pharmaceuticals,llc for the product Value Pharmapain Reliever (NDC 42787-102). 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, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, nursing mothers, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients Hydroxypropylmethyl cellulose, polyethylene glycol, starch, talc, titanium dioxide
Otc - Purpose
Purpose
Pain reliever / Fever reducer
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately
Indications & Usage
Uses provides temporary relief of: headache pain and fever of colds - muscle pain - toothache - minor pain of arthritis
Warnings
Warnings
Do not use - if you have ever had an allergic reaction to any other pain relievers/fever reducers.
Reyes 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 or 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 sever allergic reaction which may include : facial swelling - asthma (wheezing) - shock - hives
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chances are higher if you are- 60 years of age or older - have had stomach ulcer bleeding problems - take a blood thinner (anticoagulant) or steroid drug - take other drugs containing prescription or non prescription NSAIDs (aspirin, ibuprofen, naproxen, others) - have 3 or more alcoholic drinks everyday while using this product - take more or for a longer time than directed
Dosage & Administration
Directions - drink a full glass of water with each dose - Adults and children 12 years of age and over: take 1 to 2 tablets with water. Dosage may be repeated every 4 hours, not to exceed 12 tablets in 24 hours. Children under 12: consult a doctor
Nursing Mothers
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 or complications during delivery
Package Label.Principal Display Panel
Copy Of Label (Aspirin 325)
* Please review the disclaimer below.
