FDA label 60a394a5-04c7-819e-e053-2a91aa0add1f
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
- 60a394a5-04c6-819e-e053-2a91aa0add1f
- SPL ID
- 60a394a5-04c7-819e-e053-2a91aa0add1f
- Version
- 1
- Effective date
- 2017-12-18
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:22:37
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 | 60a394a5-04c7-819e-e053-2a91aa0add1f | id | |
| spl set id | 60a394a5-04c6-819e-e053-2a91aa0add1f | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse reactions The following have been associated with the use of benzphetamine hydrochloride: Cardiovascular Palpitation, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy and ischemic cardiac events associated with chronic amphetamine use. Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination with other anorectic drugs, have been reported. However, no cases of this valvulopathy have been reported when Benzphetamine Hydrochloride tablets have been used alone. CNS Overstimulation, restlessness, dizziness, insomnia, tremor, sweating, headache; rarely, psychotic episodes at recommended doses; depression following withdrawal of the drug. Gastrointestinal Dryness of the mouth, unpleasant taste, nausea, diarrhea, other gastrointestinal disturbances. Allergic Urticaria and other allergic reactions involving the skin. Endocrine Changes in libido.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.