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 (canonical bytes are SHA-256 checked before publication)

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

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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.