FDA label b8a1ab3b-8724-4c9b-bffa-d3bac1139c8c

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
02236a20-937f-45f7-800a-3b528617665f
SPL ID
b8a1ab3b-8724-4c9b-bffa-d3bac1139c8c
Version
5
Effective date
2009-12-11
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:30:08

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Do not exceed recommended dosage. Patients with persistent cough such as occur with smoking, asthma, emphysema, or where cough is accompanied by excessive secretions should not take this product. A persistent cough may be a sign of a serious condition. If the cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Do not take this product if you have chronic pulmonary disease, shortness of breath, difficulty in breathing, asthma, emphysema, high blood pressure, heart disease, diabetes, thyroid disease, or difficulty in urination due to enlargement of the prostate gland unless directed by a physician. Dexchlorpheniramine Tannate should be used with extreme caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction. Due to its mild atropine-like action, Dexchlorpheniramine Tannate should be used cautiously in patients with bronchial asthma. Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery, and may impair mental alertness in children. Antihistamines may cause hyperexcitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. Administration of Dextromethorphan Tannate may be accompanied by histamine release and should be used with caution in atopic children. Hypertensive crises can occur with concurrent use of sympathomimetic amines and monoamine oxidase (MAO) inhibitors, indomethacin, or with beta-blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted immediately. Fever should be managed by means of external cooling.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Dexchlorpheniramine Tannate: Slight to moderate drowsiness may occur and is the most frequent side effect. Other adverse reactions may include: General - Dryness of mouth, nose, and throat; thickening of bronchial secretions; dizziness, urticaria, drug rash, photosensitivity, and pruritus. Cardiovascular System - Hypotension, hypertension, cardiac arrhythmias, palpitations, tachycardia, pallor. Central Nervous System (CNS) - Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, dysphoria, restlessness, insomnia, hallucinations, and CNS depression. G.U. System - Urinary frequency, difficult urination. G.I. System - Epigastric discomfort, anorexia, nausea, vomiting, diarrhea or constipation. Respiratory System - Respiratory difficulty, tightness of chest and wheezing, shortness of breath. Hematologic System - Hemolytic anemia, thrombocytopenia, agranulocytosis.

Reported adverse events (FAERS/openFDA)#

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