FDA label beef6d9e-a7aa-488e-bfa4-af3006d1d44e

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
d559ce36-587a-4e28-8e9b-fedc37daccf5
SPL ID
beef6d9e-a7aa-488e-bfa4-af3006d1d44e
Version
2
Effective date
2010-05-26
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:51:33

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or to perform hazardous tasks while taking this drug. Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetic amines in overdosage may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage. Antihistamines should be used with considerable caution in pyloroduodenal obstruction; symptomatic prostatic hypertrophy; bladder neck obstruction. Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Do not exceed recommended dosage. Heat prostration can occur with methscopolamine used where the environmental temperature is high. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, use of methscopolamine would be inappropriate and possibly harmful.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS The following adverse reactions have been observed with the use of, chlorpheniramine, methscopolamine and phenylephrine: Arrhythmias, blood dyscrasias, CNS depression, CNS stimulation, dizziness, drowsiness, dryness of mouth, hallucinations, hypotension, hypertension, increased sensitivity of skin to sun, increased sweating, loss of appetite, paradoxical reaction, restlessness, skin rash, stomach upset or pain, thickening of mucus, tingling in hands or feet, trembling, troubled breathing, unusual tiredness or weakness, vomiting. Note: • Agitation; confusion; difficult or painful urination; drowsiness; dizziness; and dryness of mouth, nose or throat are more likely to occur in the elderly. • Nightmares, unusual excitement, nervousness, restlessness, or irritability are more likely to occur in children and the elderly. • When anticholinergics are given to patients, especially children, where the environmental temperature is high, there is risk of a rapid increase in body temperature.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.