FDA label a82239ad-c5a3-47e4-b626-63639fa01a10

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
ad22571e-f16d-46cf-885b-38cccf02becf
SPL ID
a82239ad-c5a3-47e4-b626-63639fa01a10
Version
1
Effective date
2012-06-11
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:49:06

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, narrow angle glaucoma or prostatic hypertrophy. Use with caution or avoid use in patients taking monoamine oxidase (MAO) inhibitors. This product contains antihistamines which may cause drowsiness and may have additive central nervous system (CNS) effects with alcohol or other CNS depressants (e.g., hypnotics, sedatives, tranquilizers).

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Adverse effects associated with Chlor-Tan A 12 Suspension at recommended doses have been minimal. The most common have been drowsiness, sedation, dryness of mucous membranes and gastrointestinal effects. Serious side effects with oral antihistamines or sympathomimetics have been rare. Sympathomimetic amines may cause tachycardia, palpitations, nervousness, excitability, dizziness, insomnia, restlessness, headache, gastric Irritation, and irritability. Sympathomimetic amines have been associated with certain untoward reactions including fear, anxiety, tenseness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, Insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. Hyperactive Individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea. Urinary retention may occur in patients with prostatic hypertrophy.

Reported adverse events (FAERS/openFDA)#

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