FDA label 3e83ed17-4fcb-0957-e054-00144ff88e88

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
15f3fea9-fc86-4065-b01e-4e26eafa2607
SPL ID
3e83ed17-4fcb-0957-e054-00144ff88e88
Version
2
Effective date
2016-10-10
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:31:00

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS WARNINGS 225Do not prescribe propoxyphene for patients who are suicidal or addiction-prone.225Prescribe propoxyphene with caution for patients taking tranquilizers or antidepressant drugs and patients who use alcoholin excess.225Tell your patients not to exceed the recommended dose and to limit their intake of alcohol.Propoxyphene products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are amajor cause of drug-related deaths. Fatalities within the first hour of

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS ADVERSE REACTIONSIn a survey conducted in hospitalized patients, less than 1% of patients taking propoxyphene hydrochloride at recommended dosesexperienced side effects. The most frequently reported were dizziness, sedation, nausea, and vomiting. Some of these adversereactions may be alleviated if the patient lies down.Other adverse reactions include constipation, abdominal pain, skin rashes, lightheadedness, headache, weakness, euphoria, dysphoria,hallucinations, and minor visual disturbances.Liver dysfunction has been reported in association with both active components of propoxyphene napsylate and acetaminophentablets. Propoxyphene therapy has been associated with abnormal liver function tests and, more rarely, with instances of reversiblejaundice (including cholestatic jaundice). Hepatic necrosis may result from acute overdose of acetaminophen (see OVERDOSAGE).In chronic ethanol

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.