Application Nr Approved Date Route Status External Links
ANDA040680 2006-09-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Oxycodone Hydrochloride And Acetaminophen Oral Solution Is Indicated For The Management Of Pain Severe Enough To Require An Opioid Analgesic 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 Oxycodone Hydrochloride And Acetaminophen Oral Solution 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. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
2. High Fructose Corn Syrup HIGH FRUCTOSE CORN SYRUP Unresolved
3. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
4. Potassium Sorbate POTASSIUM SORBATE Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Trisodium Citrate Dihydrate TRISODIUM CITRATE DIHYDRATE Molecular
7. Saccharin Sodium SACCHARIN SODIUM Molecular
8. Water WATER Molecular

Active Ingredients ( 2 Total)

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