Application Nr Approved Date Route Status External Links
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Indications and Purposes

1 Indications And Usage Ultracet Tablets Are Indicated For The Management Of Acute Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. Ultracet Is A Combination Of Tramadol Hydrochloride, An Opioid Agonist, And Acetaminophen, And Is Indicated For The Management Of Acute Pain, Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. ( 1 ) Limitations Of Use ( 1 ) Ultracet Tablets Are Indicated For Short-Term Use Of Five Days Or Less. Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, Reserve Ultracet For Use In Patients For Whom Alternative Treatment Options [e.g., Non-Opioid Analgesics]: Have Not Been Tolerated, Or Are Not Expected To Be Tolerated. Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia. Limitations Of Use Ultracet Tablets Are Indicated For Short-Term Use Of Five Days Or Less. Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses [see Warnings And Precautions (5.1) ] , Reserve Ultracet For Use In Patients For Whom Alternative Treatment Options [e.g., Non-Opioid Analgesics]: Have Not Been Tolerated, Or Are Not Expected To Be Tolerated, Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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