Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
Generic: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Basic Information
Manufacturer
Padagis US LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
06db369d-09fe-4ca2-b98c-705356b7c403
Indications & Usage
INDICATIONS AND USAGE For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
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.
Antihistamines may diminish mental alertness.
In the young child, they may produce excitation.
Adverse Reactions
ADVERSE REACTIONS The most frequent adverse reactions to Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral 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.
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.