Application Nr Approved Date Route Status External Links
ANDA090485 2009-12-09 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tramadol Hcl And Acetaminophen Tablets Are Indicated For The Management Of Acute Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. Limitations Of Use Tramadol Hcl And Acetaminophen 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 Tramadol Hcl And Acetaminophen Tablets 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. Tramadol Hcl And Acetaminophen Tablets Are 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) Tramadol Hcl And Acetaminophen 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 Tramadol Hcl And Acetaminophen Tablets 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 (8 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Ferric Oxide Red FERRIC OXIDE RED Molecular
3. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
7. Povidones POVIDONES Unresolved
8. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 2 Total)

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