FDA Label for Pain Free
View Indications, Usage & Precautions
Pain Free Product Label
The following document was submitted to the FDA by the labeler of this product Afassco Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredients (In Each Tablet)
Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg
Otc - Purpose
Pain reliever, Stimulant
Indications & Usage
Uses: For the temporary relief of pain from:
• headaches • colds • muscular aches
• menstrual cramps • toothaches
• minor arthritic pain • backaches
Warnings
Warnings:
Reye's Syndrome: 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), or have 3 or more alcoholic drinks every day while using this product.
Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory 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, or take more or for a longer time than directed.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health care professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions:
Adults and children: (12 years and older) Take 1 to 2 tablets with a full glass of water every 4 hours as needed. Do not exceed 6
tablets in 24 hours, or as directed by doctor.
Children: (under 12 years) Do not give to children under 12 years of age
Inactive Ingredient
SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION
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