warnings
WARNINGS Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. Antihistamines may diminish mental alertness. In the young child, they may produce excitation.
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
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
- Brand name
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
- Generic name
- BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 01ea6357-24dc-4056-9fd2-9e643650b91f
- SPL ID
- 44a05fe1-89fe-4252-b0b8-1ce678a4c6a7
- Version
- 7
- Effective date
- 2025-09-04
- 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 01:46:32
| Harmonized routes |
|---|
| ORAL |
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 |
|---|---|---|---|
| application applno | ANDA | 202940 | derived:openfda.application_number |
| application number | ANDA202940 | openfda.application_number | |
| brand name | Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | openfda.brand_name | |
| generic name | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | openfda.generic_name | |
| manufacturer name | PAI Holdings, LLC dba PAI Pharma | openfda.manufacturer_name | |
| ndc | package | 0121-0933-16 | openfda.package_ndc |
| ndc | package | 0121-0933-04 | openfda.package_ndc |
| ndc | product | 0121-0933 | openfda.product_ndc |
| ndc11 | package | 00121093304 | derived:openfda.package_ndc |
| ndc11 | package | 00121093316 | derived:openfda.package_ndc |
| rxcui | 1357010 | openfda.rxcui | |
| spl id | 44a05fe1-89fe-4252-b0b8-1ce678a4c6a7 | id | |
| spl set id | 01ea6357-24dc-4056-9fd2-9e643650b91f | set_id | |
| unii | 9D2RTI9KYH | openfda.unii | |
| unii | 6V9V2RYJ8N | openfda.unii | |
| unii | IXA7C9ZN03 | openfda.unii |
Warnings cross-check#
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Adverse reactions cross-check#
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adverse reactions
ADVERSE REACTIONS The most frequent adverse reactions to brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include: Dermatologic: Urticaria, drug rash, photosensitivity, pruritus. Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias, palpitation. CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, 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. Respiratory System: Tightness of chest and wheezing, shortness of breath. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis. To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or HYPERLINK "http://www.fda.gov/medwatch" www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.