FDA label 5a66dddc-4192-4971-9f4c-8c94f6a0b741
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
- 4c386261-5f80-4317-a5e9-852a76f06f11
- SPL ID
- 5a66dddc-4192-4971-9f4c-8c94f6a0b741
- Version
- 3
- Effective date
- 2019-01-25
- Source export date
- 2026-10-12
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:42:57
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 | 5a66dddc-4192-4971-9f4c-8c94f6a0b741 | id | |
| spl set id | 4c386261-5f80-4317-a5e9-852a76f06f11 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: Do not exceed recommended dosage. If rapid pulse, dizziness, or blurring of vision occurs discontinue use immediately.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: Please report Adverse Reactions to SJ Pharmaceuticals; Attention: Adverse Reactions; 1212 Collier Rd. NW Atlanta, GA 30318. (877) 604-7575 Cardiovascular -rapid pulse, flushing Central Nervous system -blurred vision, dizziness Respiratory -shortness of breath or trouble breathing Genitourinary -difficult micturition, acute urinary retention Gastrointestinal -dry mouth, nausea/vomiting
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.