FDA label 36fed1e2-4bbe-5d14-e054-00144ff8d46c
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
- c4adaaef-cb23-4e29-8645-347578beb60a
- SPL ID
- 36fed1e2-4bbe-5d14-e054-00144ff8d46c
- Version
- 4
- Effective date
- 2016-07-05
- Source export date
- 2026-09-28
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:49:53
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 | 36fed1e2-4bbe-5d14-e054-00144ff8d46c | id | |
| spl set id | c4adaaef-cb23-4e29-8645-347578beb60a | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Tolerance to the anorectic effect usually develops within a few weeks. When this occurs, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued. Use of phendimetrazine within 14 days following the administration of monoamine oxidase inhibitors may result in a hypertensive crisis. Abrupt cessation of administration following prolonged high dosage results in extreme fatigue and depression. Because of the effect on the central nervous system phendimetrazine tartrate may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Cardiovascular: Palpitation, tachycardia, elevation of blood pressure. Central Nervous System: Overstimulation, restlessness, dizziness, insomnia, tremor, headache; rarely psychotic episodes at recommended doses, agitation, flushing, sweating, blurring of vision. Gastrointestinal: Dryness of the mouth, diarrhea, constipation, nausea, stomach pain. Genitourinary: Changes in libido, urinary frequency, dysuria.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.