FDA label 3c80d5b3-0fa7-4342-b4d1-38c4d294e050

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
a70414bd-08fa-46da-9d53-3a9ceebba1f0
SPL ID
3c80d5b3-0fa7-4342-b4d1-38c4d294e050
Version
2
Effective date
2010-12-11
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 01:29:42

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Antihistamines may diminish mental alertness, and may cause hyperexcitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Do not exceed the recommended dosage. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children. Do not give this product to children who have a chronic pulmonary disease, breathing problems such as chronic bronchitis, glaucoma, or those who are taking sedatives or tranquilizers without first consulting with a doctor. Considerable caution should be exercised in patients with hypertension, diabetes, ischemic heart disease, hyperthyroidism, increased intraocular pressure, renal impairment, and prostatic hypertrophy. Do not give this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS The most frequent adverse reactions to Chlorphen Mal/Dex HBr/Pseudoeph HCl 0.8/3/9 mg Drops include: sedation; drowsiness; dryness of mouth, nose, and throat; thickening of bronchial secretions; and dizziness. Other adverse reactions may include: Dermatologic – urticaria, drug rash, photosensitivity, pruritus. Cardiovascular System – hypotension, hypertension, cardiac arrhythmias, palpitation. Central Nervous System (CNS) – disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsion, headache, euphoria, and dysphoria. G.U. System – urinary frequency, difficult urination. G.I. System – epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation. Respiratory System – tightness of chest and wheezing, shortness of breath. Hematologic System – hemolytic anemia, thrombocytopenia, agranulocytosis. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Reported adverse events (FAERS/openFDA)#

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