Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide (Page 2 of 2)

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.

Treatment:

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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

RECOMMENDED STORAGE

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

Distributed by:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30005
1-800-541-4802

L-0038 Rev 0919-01

500454-06

PRINCIPAL DISPLAY PANEL

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.

Rx Only

NET: 4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL

ACELLA Pharmaceuticals LLC

NDC 42192-607-16

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup

DO NOT USE IF INNER FOIL SEAL IS
BROKEN OR MISSING.

Rx Only

NET: 16 fl oz (473 mL)

PRINCIPAL DISPLAY PANEL

ACELLA Pharmaceuticals LLC

NDC 42192-607-05

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup

Rx Only

NET: 16 fl oz (473 mL)

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-607 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN METHYLPARABEN PROPYLENE GLYCOL SODIUM BENZOATE SODIUM CITRATE SUCRALOSE WATER

Product Characteristics Color pink Score Shape Size Flavor WATERMELON Imprint Code Contains

Packaging # 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 3 NDC:42192-607-16 473 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203375 09/21/2016

Labeler — Acella Pharmaceuticals, LLC (825380939)

Revised: 11/2022 Acella Pharmaceuticals, LLC