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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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