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
- 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
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 | 3c80d5b3-0fa7-4342-b4d1-38c4d294e050 | id | |
| spl set id | a70414bd-08fa-46da-9d53-3a9ceebba1f0 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.