FDA label c3e8915d-15c0-418d-9450-696ed06f4c76
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
- c9f98c9a-73ec-4d65-99af-a3151bb1a836
- SPL ID
- c3e8915d-15c0-418d-9450-696ed06f4c76
- Version
- 2
- Effective date
- 2010-01-08
- Source export date
- 2026-10-12
- 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/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:36:08
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 | c3e8915d-15c0-418d-9450-696ed06f4c76 | id | |
| spl set id | c9f98c9a-73ec-4d65-99af-a3151bb1a836 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Caution should be exercised in patients with stenosing peptic ulcer, pyloroduodenal obstruction, or bladder-neck obstruction, hypertension, diabetes mellitus, ischemic heart diseases, hyperthyroidism, increased intraocular pressure narrow angle glaucoma and prostatic hypertrophy. Patients sixty (60) years and older may demonstrate an increased response to this drug combination, both in therapeutic effect and in the incidence of adverse reactions and hence a lower dose may be more appropriate for these patients. Antihistamines and/or decongestants may cause excitability particularly in children. At doses higher than the recommended dose, nervousness, dizziness or sleeplessness may occur.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The physician should be alert to the possibility of any of the adverse reactions which have been observed with sympathomimetic and antihistaminic drugs. These include: drowsiness; confusion, restlessness, nausea, vomiting, drug rash, vertigo, palpitation, anorexia, dizziness, dysuria due to vesicle sphincter spasm, headache, insomnia, anxiety, tension, weakness, tachycardia, angina, sweating, blood pressure elevation, mydriasis, gastric distress, abdominal cramps, central nervous system stimulation and circulatory collapse.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.