FDA drug label 5021a19a: US FDA label indications

Indications and usage (label excerpt)

1. INDICATIONS AND USAGE Oxycodone Hydrochloride Oral Solution, USP is an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe acute and chronic pain where the use of an opioid analgesic is appropriate.

Warnings (label excerpt)

5. WARNINGS AND PRECAUTIONS 5.1 Risk of Medication Errors Use caution when prescribing, dispensing, and administering Oxycodone Hydrochloride Oral Solution to avoid dosing errors due to confusion between mg and mL, and other oxycodone solutions with different concentrations, which could result in accidental overdose and death. Use caution to ensure the dose is communicated clearly and dispensed accurately. Always use the enclosed calibrated measuring cup when administering Oxycodone Hydrochloride Oral Solution to ensure the dose is measured and administered accurately. 5.2 Respiratory Depression Respiratory depression is the primary risk of Oxycodone Hydrochloride Oral Solution. Respiratory depression occurs most frequently in elderly or debilitated patients, and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation, or following large initial doses in…

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