FDA label da0602ba-cc03-4216-965a-5dd06ad61e67
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
- 41633813-9b18-4ab4-9f60-66f25e2e6c27
- SPL ID
- da0602ba-cc03-4216-965a-5dd06ad61e67
- Version
- 2
- Effective date
- 2011-08-24
- Source export date
- 2026-10-12
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:06:16
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 | da0602ba-cc03-4216-965a-5dd06ad61e67 | id | |
| spl set id | 41633813-9b18-4ab4-9f60-66f25e2e6c27 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Patients with persistent cough such as occurs 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. Use caution when giving to children or patients with chronic pulmonary disease, shortness of breath, difficulty 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. Antihistamine 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. Do not exceed the recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. Administration of dextromethorphan 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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The most frequent adverse reactions to Bromhist-PDX Syrup include sedation; dryness of mouth, nose, and throat; thickening of bronchial secretins; dizziness. Other adverse reactions may include: Dermatologic - Urticaria, drug rash, photosensitivity, and pruritus. Cardiovascular System - Hypotension, hypertension, cardiac arrhythmias, palpitations, tachycardia, pallor. Central Nervous System (CNS) - Distrubed 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.