Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide (Page 2 of 2)
Acella Pharmaceuticals, LLC 18 November 2022
Pediatric Use:
Safety and effectiveness in pediatric patients below the age of 6 months have not been established (see DOSAGE AND ADMINISTRATION).
Adverse Reactions to Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide
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.
OVERDOSAGE
Signs and Symptoms:
Central nervous system effects from overdosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted. Toxic doses of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias; signs of CNS depression may occasionally be seen. Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures.
Toxic Doses:
Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug. A 2½-year-old child survived the ingestion of 21 mg/kg of dextromethorphan exhibiting only ataxia, drowsiness, and fever, but seizures have been reported in 2 children following the ingestion of 13–17 mg/kg. Another 2½-year-old child survived a dose of 300–900 mg of brompheniramine. The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg.
Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances tracheostomy may be necessary prior to lavage. Naloxone hydrochloride 0.005 mg/kg intravenously may be of value in reversing the CNS depression that may occur from an overdose of dextromethorphan. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated.
Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours. Children 2 to under 6 years of age: 2.5 mL (½ teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician.
Do not exceed 6 doses during a 24-hour period.
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a pink, sugar free syrup with a melon flavor. Each 5 mL (1 teaspoonful) contains: brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following sizes:
5 mL unit dose cups, boxes of 40: 42192-607-40
4 fl oz (118 mL) NDC 42192-607-04
16 fl oz (473 mL) NDC 42192-607-16
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
KEEP TIGHTLY CLOSED
Dispense in a tight, light-resistant container as defined in the USP.
Rx Only
Acella Pharmaceuticals, LLC
L-0038 Rev 0919-01
ACELLA Pharmaceuticals LLC
NDC 42192-607-04
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup
DO NOT USE IF INNER FOIL SEAL IS
BROKEN OR MISSING.
NET: 4 fl oz (118 mL)
(click image for full-size original)
NET: 16 fl oz (473 mL)
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-607
Route of Administration ORAL DEA Schedule
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE 2 mg in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL
FD&C RED NO. 40
Color pink Score
Shape Size
Flavor WATERMELON Imprint Code
# Item Code Package Description Multilevel Packaging
1 NDC:42192-607-40 40 CUP, UNIT-DOSE in 1 CASE contains a CUP, UNIT-DOSE (42192-607-05)
1 NDC:42192-607-05 5 mL in 1 CUP, UNIT-DOSE This package is contained within the CASE (42192-607-40)
2 NDC:42192-607-04 118 mL in 1 BOTTLE, PLASTIC None
Labeler — Acella Pharmaceuticals, LLC (825380939)
Revised: 11/2022 Acella Pharmaceuticals, LLC
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Brand names beginning with the letter 'B' (Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide).
Medications with generic name beginning with the letter 'B' (Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide).
Medication information from November 2022, newest first or November 2022, earliest first.
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