Application Nr Approved Date Route Status External Links
ANDA040779 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Acetaminophen And Codeine Phosphate 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 ), Reserve Acetaminophen And Codeine Phosphate Tablets For Use In Patients For Whom Alternative Treatment Options (e.g., Non-Opioid Analgesics). Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia, Have Not Been Tolerated, Or Are Not Expected To Be Tolerated.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Comments