Bromfed DM

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Brom/PSE/DM Cough

Dosage form: liquid
Ingredients: BROMPHENIRAMINE MALEATE 2mg in 5mL, PSEUDOEPHEDRINE HYDROCHLORIDE 30mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL
Labeler: Macoven Pharmaceuticals
NDC code: 44183-220

Brom/PSE/DM Cough Syrup

Active ingredients (in each 5 mL)	Purpose
Brompheniramine Maleate 2 mg	Antihistamine
Pseudoephedrine HCl 30 mg	Nasal Decongestant
Dextromethorphan HBr 10 mg	Cough Suppressant

• runny nose
• sneezing
• itching of the nose and throat
• itching, watery eyes due to hay fever or other upper respiratory allergies
• nasal congestion due to the common cold
• cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
• the impulse to cough to help you get to sleep

• may cause excitability, or increased irritability especially in children
• Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

• heart disease
• diabetes
• glaucoma
• thyroid disease
• high blood pressure
• trouble urinating due to enlarged prostate gland
• persistent or chronic cough such as occurs with emphysema, chronic bronchitis or asthma
• cough accompanied by too much phlegm (mucus)

• if you or your child are taking sedatives or tranquilizers

• marked drowsiness may occur
• do not exceed recommended dosage
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery

• nervousness, dizziness, or sleeplessness occurs
• symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. 800-222-1222

Americans see their primary care doctors less often than they did a decade ago. Adults under 65 made nearly 25% fewer visits to primary care providers in 2016 than they did in 2018, according to National Public Radio. In the same time period, the number of adults who went at least a year without visiting a primary care provider increased from 38% to 46%.

• take every 4 hours
• do not take more than 4 doses in 24 hours or as directed by a doctor

Adults and children 12 years of age and older	2 teaspoonsful
Children 6 to under 12 years of age	1 teaspoonful
Children 4 to under 6 years of age	1/2 teaspoonful

Do Not Use in Children under 4 years of age

Other information

Store at 25°C (77°F): Excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Temperature)

• Tamper Evident: Do not use if seal is broken or missing.
• Protect from freezing.

Inactive ingredients

Alcohol Dehydrated, Butter Scotch Flavor, Citric Acid Anhydrous, FD&C Red #40, Glycerin, High Fructose Corn Syrup, Methyl Paraben, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate.

Manufactured for: Macoven Pharmaceuticals, LLC
Magnolia, TX 77354

PRINCIPAL DISPLAY PANEL – 473 mL Bottle Label

ANTIHISTAMINE, NASAL DECONGESTANT,
COUGH SUPPRESSANT

Butter Scotch Flavor

Each 5 mL (one teaspoonful) for oral administration contains:
Brompheniramine Maleate	2 mg
Pseudoephedrine HCl	30 mg
Dextromethorphan HBr	10 mg

16 fl. oz. (473 mL)

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:44183-220
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
ALCOHOL
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
METHYLPARABEN
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE

Product Characteristics
Color	RED	Score
Shape	Size
Flavor	BUTTERSCOTCH	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:44183-220-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/05/2012

Labeler – Macoven Pharmaceuticals (832591965)

Revised: 01/2012
Document Id: e6ccd6e8-7156-41b4-9dd1-a101cf78260c
Set id: 4e81f64f-73aa-462f-86af-a1ab2a840271
Effective Time: 20120110
Macoven Pharmaceuticals

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum™ (updated 6 Feb 2023), ASHP (updated 11 Jan 2023) and others.

Bromfed DM

Generic name: brompheniramine, dextromethorphan, and pseudoephedrine [ brom-fen-EER-a-meen, dex-troe-me-THOR-fan, soo-doe-e-FED-rin ]
Brand names: Allanhist PDX Drops, Anaplex DM, Andehist DM NR Syrup, Bromaline DM, Bromfed DM, . show all 14 brands Bromhist PDX, Bromplex DM, Brotapp-DM, BroveX PSE DM, Dimetane DX, Neo DM, Q-Tapp DM, Resperal-DM Drops, Robitussin Allergy & Cough
Drug class: Upper respiratory combinations

Medically reviewed by Drugs.com on Oct 6, 2021. Written by Cerner Multum.

What is Bromfed DM?

Brompheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Bromfed DM is a combination medicine used to treat cough, runny or stuffy nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.

Bromfed DM will not treat a cough that is caused by smoking, asthma, or emphysema.

Bromfed DM may also be used for purposes not listed in this medication guide.

Warnings

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Before taking this medicine

Do not use Bromfed DM if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

To make sure Bromfed DM is safe for you, tell your doctor if you have:

• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
• a blockage in your digestive tract (stomach or intestines);
• high blood pressure, heart disease;
• liver or kidney disease;
• glaucoma;
• cough with mucus, or cough caused by emphysema or chronic bronchitis;
• enlarged prostate or urination problems;
• pheochromocytoma (an adrenal gland tumor);
• overactive thyroid; or
• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

FDA pregnancy category C. It is not known whether Bromfed DM will harm an unborn baby. Do not use this medicine without a doctor’s advice if you are pregnant.

This medicine can pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without a doctor’s advice if you are breast-feeding a baby.

How should I take Bromfed DM?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Dosage – adults and children 12 years and over: 2 teaspoonfuls every 4 hours. Children 6 to under 12 years: 1 teaspoonful every 4 hours. Children 2 to under 6 years of age: half a teaspoonful every 4 hours. Infants 6 months to under 2 years of age: dosage to be established by a physician. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since Bromfed DM is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Bromfed DM?

Drinking alcohol can increase certain side effects of brompheniramine, dextromethorphan, and pseudoephedrine.

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines and cough suppressants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or cough suppressant.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Brompheniramine and pseudoephedrine can decrease sweating and you may be more prone to heat stroke.

Bromfed DM side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Bromfed DM and call your doctor at once if you have:

• confusion, severe anxiety, hallucinations, tremors;
• weak or shallow breathing;
• a light-headed feeling, like you might pass out;
• fast or pounding heartbeats;
• painful or difficult urination, little or no urinating;
• pale skin, weakness, easy bruising or bleeding, fever, chills, body aches; or
• increased blood pressure–severe headache, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats.

Common side effects may include:

• dizziness, drowsiness, headache;
• constipation, upset stomach, loss of appetite;
• blurred vision, double vision, dry eyes;
• sleep problems (insomnia); or
• dry mouth, nose, or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect this medicine?

Tell your doctor about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking Bromfed DM with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Where can I get more information?

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Frequently asked questions

More about Bromfed DM (brompheniramine / dextromethorphan / pseudoephedrine)

• Check interactions
• Reviews (27)
• Side effects
• Dosage information
• Drug class: upper respiratory combinations

Patient resources

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Professional resources

Related treatment guides

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2023 Cerner Multum, Inc. Version: 7.06.

Brompheniramine; Pseudoephedrine; Dextromethorphan oral solution

BROMPHENIRAMINE; PSEUDOEPHEDRINE; DEXTROMETHORPHAN (brome fen IR a meen; soo doe e FED rin; dex troe meth OR fan) is a combination of an antihistamine, decongestant, and cough suppressant. It is used to treat cough and the symptoms of allergy and colds. This medicine will not treat an infection.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Anaplex, Anaplex DM, Andehist DM, Andehist DM NR, Brom/PSE/DM Cough, Bromaline DM, Bromatane DX, Bromaxefed DM RF, Bromdex D, Brometane DX, Bromfed-DM, Bromophed DX, Bromphenex DM, Bromplex DM, Brotapp-DM, BroveX PSB DM, Carbofed DM, Cardec DM, Dallergy DM, Decon DM, Dimetane DX, Dimetapp Children’s DM Cold and Cough, Dynatuss, EndaCof-DM, LoHist PSB DM, Myphetane DX, Neo DM, PBM Allergy, Q-Tapp DM, Robitussin Cough and Allergy, Rondamine DM, Rondec DM, Sildec DM, Tuss Mine DM

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• blockage in your bowels
• diabetes (high blood sugar)
• glaucoma
• heart disease
• high blood pressure
• kidney disease
• lung or breathing disease (asthma, COPD)
• prostate disease
• stomach ulcers, other stomach or intestine problems
• taken an MAOI such as Marplan, Nardil, or Parnate in last 14 days
• thyroid disease
• an unusual or allergic reaction to brompheniramine, pseudoephedrine, dextromethorphan, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Take it as directed on the label. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Do not take it more often than directed.

Talk to your health care provider about the use of this medicine in children. While this drug may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Patients over 65 years of age may have a stronger reaction to this medicine and need smaller doses.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medicine is not for regular use. It should only be used as needed.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
• MAOIs like Marplan, Nardil, and Parnate
• ozanimod

This medicine may also interact with the following medications:

• alcohol
• certain medicines for anxiety or sleep
• certain medicines for depression like amitriptyline, fluoxetine, sertraline
• certain medicines for seizures like phenobarbital, primidone
• general anesthetics like halothane, isoflurane, methoxyflurane, propofol
• medicines for blood pressure
• medicines that relax muscles for surgery
• narcotic medicines for pain
• other antihistamines for allergy, cough, and cold
• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your health care provider if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives, swelling of the face, lips, or tongue)
• increase in blood pressure
• seizures
• serotonin syndrome (irritable; confusion; diarrhea; fast or irregular heartbeat; muscle twitching; stiff muscles; trouble walking; sweating; high fever; seizures; chills; vomiting)
• trouble passing urine

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• anxious
• dizziness
• dry mouth
• trouble sleeping
• unusually weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, pour the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.