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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

Drug Facts

Active ingredients
(in each 5 mL)
Purpose
Brompheniramine Maleate 2 mgAntihistamine
Pseudoephedrine HCl 30 mgNasal Decongestant
Dextromethorphan HBr 10 mgCough Suppressant

Uses

temporarily relieves

  • 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

Warnings
  • 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.

Ask a doctor before use if you have
  • 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)

Ask a doctor or pharmacist before use
  • if you or your child are taking sedatives or tranquilizers

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

Stop use and ask a doctor if
  • 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

Directions
  • 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 older2 teaspoonsful
Children 6 to under 12 years of age1 teaspoonful
Children 4 to under 6 years of age1/2 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.

Questions?

Call 1-877-622-6836

Manufactured for: Macoven Pharmaceuticals, LLC
Magnolia, TX 77354

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 44183-220-16

Brom/PSE/DM
Cough Syrup

ANTIHISTAMINE, NASAL DECONGESTANT,
COUGH SUPPRESSANT

Butter Scotch Flavor

Each 5 mL (one teaspoonful) for
oral administration contains:
Brompheniramine Maleate2 mg
Pseudoephedrine HCl30 mg
Dextromethorphan HBr10 mg

16 fl. oz. (473 mL)

MACOVEN
PHARMACEUTICALS

BROM/PSE/DM   COUGH
brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44183-220
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE2 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScore    
ShapeSize
FlavorBUTTERSCOTCHImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:44183-220-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/05/2012
Labeler - Macoven Pharmaceuticals (832591965)

Revised: 01/2012
 
Macoven Pharmaceuticals

Further information

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