Application Nr Approved Date Route Status External Links
NDA022402 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Codeine Sulfate Tablets Are Indicated For The Management Of Mild To Moderate Pain, Where Treatment With An Opioid Is Appropriate And For Which Alternative Treatments Are Inadequate. Limitations Of Use: Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses [See Warnings And Precautions ( 5.1 )], Reserve Codeine Sulfate Tablets For Use In Patients For Whom Alternative Treatment Options [E.g., Non-Opioid Analgesics Or Opioid Combination Products]: • Have Not Been Tolerated, Or Are Not Expected To Be Tolerated. • Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia. Codeine Sulfate Tablets Are An Opioid Agonist, Indicated For The Management Of Mild To Moderate Pain, Where Treatment With An Opioid Is Appropriate And For Which Alternative Treatments Are Inadequate. ( 1 ) Limitations Of Use ( 1 ): Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, Reserve Codeine Sulfate Tablets For Use In Patients For Whom Alternative Treatment Options [E.g., Non-Opioid Analgesics Or Opioid Combination Products]: • 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 ( 1 Total)

Name Structure ZINC ID(s)
1. Codeine Sulfate CODEINE SULFATE ZINC3806721

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