PAIN FREE PLUS- acetaminophen, aspirin, caffeine tablet
Afassco Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Uses: For the temporary relief of pain from:
• headaches • muscular aches
• menstrual cramps • toothaches
• minor arthritic pain • colds
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.
PAIN FREE PLUS
acetaminophen, aspirin, caffeine tablet |
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Labeler - Afassco Inc. (609982723) |
Registrant - ULTRAtab Laboratories, Inc. (151051757) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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ULTRAtab Laboratories, Inc. | 151051757 | manufacture(51532-0560) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Ultra Seal Corporation | 085752004 | pack(51532-0560) |