Otc - Active Ingredient
Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg
Pain Free Plus
FDA Label NDC 51532-0560
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Afassco Inc. for the product Pain Free Plus (NDC 51532-0560). 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 - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Pin reliever, Stimulant
Indications & Usage
Uses: For the temporary relief of pain from:
• headaches • muscular aches
• menstrual cramps • toothaches
• minor arthritic pain • colds
Warnings
WARNING:
Reye's Syndrome Warning: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s Syndrome, a rare but serious illness reported to be associated with aspirin.
Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours
• with other drugs containing acetaminophen (prescription or non-prescription)
• 3 or more alcoholic drinks every day while using this product.
Stomach Bleeding Warning: This product contains nonsteroidal antiinflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you: have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug
• are age 60 or older • have 3 or more alcoholic drinks every day while using this product • take with other drugs containing an NSAID • take more or for a longer time than directed.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
DIRECTIONS:
Adults: 2 tablets with a full glass of water every 6 hours as needed. Do not exceed 8 tablets in a 24 hour period.
Children under 12 years of age: Consult a doctor.
Inactive Ingredient
SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION
Package Label.Principal Display Panel
Afassco Pain Free Plus (Afassco Painfreeplus)
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