FDA label 9e54cbcc-5107-48f9-b080-fe41dba93472

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
74b92bdf-5447-4932-a265-39891a4557a4
SPL ID
9e54cbcc-5107-48f9-b080-fe41dba93472
Version
2
Effective date
2013-04-24
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:47:26

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 hyperthyroidism, increased intraocular pressure and prostatic hypertrophy. Patients sixty (60) years and older may demonstrate an increased response to this drug, both in therapeutic effect and in the incidence of adverse reactions. A reduction in dosage may be more appropriate for these patients. Antihistamines may cause drowsiness or 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 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; circulatory collapse.

Reported adverse events (FAERS/openFDA)#

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