ACETAMINOPHEN
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acetaminophen tablet
Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals
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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for the temporary relief of minor aches and pains due to:
Liver warnings: This product contains acetaminophen.The maximum daily dose of this product is 6 tablets (3000 mg) in 24 hours. Severe liver damage may occur if you take
with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product
Taking more than the recommended dose(overdose) may cause liver damage.In the case of overdose get medical help or contact a Poison Control Center right away(1-800-222-1222).Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not take more than directed(see overdose warning)
Adults and children 12 years and over:
children under 12 years: ask a doctor.
If you have any questions or comments, or to report an adverse event, please contact 1-800 medline.
ACETAMINOPHEN
acetaminophen tablet |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part343 | 04/04/2012 |
Labeler - Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals (055942270) |
Registrant - Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals (055942270) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals | 055942270 | manufacture |
Revised: 04/2012 Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals