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
- 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
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 | a82239ad-c5a3-47e4-b626-63639fa01a10 | id | |
| spl set id | ad22571e-f16d-46cf-885b-38cccf02becf | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.