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Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
Overview
What is BromfedDM?
Bromfed DM Cough Syrup is a clear, light pink syrup with a butterscotch flavor.
Each 5 mL (1 teaspoonful) contains:
Brompheniramine Maleate, USP . . . . . . . . 2 mg
Pseudoephedrine Hydrochloride, USP . . . . . 30 mg
Dextromethorphan Hydrobromide, USP . . . 10 mg
Alcohol 0.95% v/v
In a palatable, aromatic vehicle.
Inactive Ingredients: artificial butterscotch flavor, citric acid anhydrous, dehydrated alcohol, FD&C Red No. 40, glycerin, liquid sugar, methylparaben, propylene glycol, purified water and sodium benzoate. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0.
Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.
What does BromfedDM look like?
What are the available doses of BromfedDM?
Sorry No records found.
What should I talk to my health care provider before I take BromfedDM?
Sorry No records found
How should I use BromfedDM?
For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
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.
What interacts with BromfedDM?
Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan in patients receiving monoamine oxidase (MAOI) inhibitors (see ).
Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
What are the warnings of BromfedDM?
Before QUADRAMET is administered, consideration should be given to the patient’s current clinical and hematologic status and bone marrow response history to treatment with myelotoxic agents. Metastatic prostate and other cancers can be associated with disseminated intravascular coagulation (DIC); caution should be exercised in treating cancer patients whose platelet counts are falling or who have other clinical or laboratory findings suggesting DIC. Because of the unknown potential for additive effects on bone marrow, QUADRAMET should not be given concurrently with chemotherapy or external beam radiation therapy unless the clinical benefits outweigh the risks. Use of QUADRAMET in patients with evidence of compromised bone marrow reserve from previous therapy or disease involvement is not recommended unless the potential benefits of the treatment outweigh the risks. Blood counts should be monitored weekly for at least 8 weeks, or until recovery of adequate bone marrow function.
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.
What are the precautions of BromfedDM?
General
Because of its antihistamine component, Bromfed DM Cough Syrup should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, Bromfed DM Cough Syrup should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.
Information for Patients
Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.
Drug Interactions
Monoamine oxidase (MAO) inhibitors
Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing dextromethorphan. In addition, MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines and may enhance the effect of pseudoephedrine. Concomitant administration of Bromfed DM Cough Syrup and MAO inhibitors should be avoided (see ).
Central nervous system (CNS) depressants
Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.).
Antihypertensive drugs
Sympathomimetic may reduce the effects of antihypertensive drugs.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies of Bromfed DM Cough Syrup to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.
Pregnancy
Nursing Mothers
Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Bromfed DM Cough 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
What are the side effects of BromfedDM?
The most frequent adverse reactions to Bromfed DM Cough Syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:
Dermatologic:
Cardiovascular System:
CNS:
G.U. System:
G.I. System:
Respiratory System:
Hematologic System:
What should I look out for while using BromfedDM?
Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan in patients receiving monoamine oxidase (MAOI) inhibitors (see ).
Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
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.
What might happen if I take too much BromfedDM?
How should I store and handle BromfedDM?
Store dust mite extract at 2°-8 °C (36° to 46°F).Keep dust mite extract at 2°-8 °C (36° to 46°F) during office use.Dilutions of concentrated extract result in a glycerin content of less than 50% which results in reduced stability of the extracts. 1:100 dilutions should be kept no longer than a month, and more dilute solutions no more than a week. The potency of a dilution can be checked by skin test comparison to a fresh dilution of the extract on a known mite allergic individual.Store dust mite extract at 2°-8 °C (36° to 46°F).Keep dust mite extract at 2°-8 °C (36° to 46°F) during office use.Dilutions of concentrated extract result in a glycerin content of less than 50% which results in reduced stability of the extracts. 1:100 dilutions should be kept no longer than a month, and more dilute solutions no more than a week. The potency of a dilution can be checked by skin test comparison to a fresh dilution of the extract on a known mite allergic individual.Store dust mite extract at 2°-8 °C (36° to 46°F).Keep dust mite extract at 2°-8 °C (36° to 46°F) during office use.Dilutions of concentrated extract result in a glycerin content of less than 50% which results in reduced stability of the extracts. 1:100 dilutions should be kept no longer than a month, and more dilute solutions no more than a week. The potency of a dilution can be checked by skin test comparison to a fresh dilution of the extract on a known mite allergic individual.Bromfed DM Cough Syrup is a clear, light pink-colored, butterscotch-flavored 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:
