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

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup. It is also not known whether brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed. Reproduction studies of brompheniramine maleate (a component of brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup) in rats and mice at doses up to 16 times the maximum human doses have revealed no evidence of impaired fertility or harm to the fetus.

Nursing Mothers

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is contraindicated in nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 months have not been established (see DOSAGE AND ADMINISTRATION).

Geriatric Use

Clinical studies of brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients. The elderly are also more likely to experience adverse reactions to sympathomimetics.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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.

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 clear, sweet, unflavored, pink syrup containing in each 5 mL (1 teaspoonful) brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following sizes:

NDC 0121-0933-04: 4 fl oz (118 mL) bottle
NDC 0121-0933-16: 16 fl oz (473 mL) bottle

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

MANUFACTURED For

Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com

PRINCIPAL DISPLAY PANEL — 118 mL Bottle Label

NDC 0121- 0933 -04

Brompheniramine Maleate,
Pseudoephedrine Hydrochloride
and Dextromethorphan Hydrobromide
Oral Solution

2 mg/ 30 mg/ 10 mg/ 5 mL

Each 5 mL (teaspoonful) contains:

Brompheniramine Maleate, USP 2 mg
Pseudoephedrine Hydrochloride, USP 30 mg
Dextromethorphan Hydrobromide, USP 10 mg

Usual Dosage: See accompanying insert.

WARNINGS: KEEP THIS AND DRUGS OUT OF THE REACH OF
CHILDREN. In case of accidental overdose, seek professional
assistance or contact a Poison Control Center immediately.

Rx only
4 fl oz (118 mL)

pai
Pharmaceutical
Associates, Inc.
Greenville, SC 29605

PRINCIPAL DISPLAY PANEL -- 118 mL Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 473 mL Bottle Label

NDC 0121- 0933 -16

Brompheniramine Maleate,
Pseudoephedrine Hydrochloride and
Dextromethorphan Hydrobromide
Oral Solution

2 mg/ 30 mg/ 10 mg/ 5 mL

Each 5 mL (teaspoonful) contains:

Brompheniramine Maleate, USP 2 mg
Pseudoephedrine Hydrochloride, USP 30 mg
Dextromethorphan Hydrobromide, USP 10 mg

Usual Dosage: See accompanying insert.

WARNINGS: KEEP THIS AND DRUGS OUT OF
THE REACH OF CHILDREN. In case of accidental
overdose, seek professional assistance or contact
a Poison Control Center immediately.

Rx only
16 fl oz (473 mL)

pai
Pharmaceutical
Associates, Inc.
Greenville, SC 29605

PRINCIPAL DISPLAY PANEL -- 473 mL Bottle Label
(click image for full-size original)

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-0933
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
GLYCERIN
METHYLPARABEN
FD&C RED NO. 40
WATER
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE
SUCROSE
Product Characteristics
Color pink Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0121-0933-04 118 mL in 1 BOTTLE None
2 NDC:0121-0933-16 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202940 03/03/2022
Labeler — Pharmaceutical Associates, Inc. (044940096)
Registrant — Trirx Huntsville Pharmaceutical Services, LLC (117090286)
Establishment
Name Address ID/FEI Operations
Trirx Huntsville Pharmaceutical Services, LLC 117090286 manufacture (0121-0933)

Revised: 06/2022 Pharmaceutical Associates, Inc.

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