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
- 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
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 3e83ed17-4fcb-0957-e054-00144ff88e88 | id | |
| spl set id | 15f3fea9-fc86-4065-b01e-4e26eafa2607 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.