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Name:Bromphenexdm
Manufacturer:Breckenridge Pharmaceutical, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Bromphenex™ DM

BROMPHENEX DM - pseudoephedrine hydrochloride, dextromethorphan hydrobromide and brompheniramine maleate liquid 
Breckenridge Pharmaceutical, Inc.

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.

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Bromphenex™ DM

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Purpose
Brompheniramine Maleate, USP 4 mg Antihistamine
Dextromethorphan HBr, USP 30 mg Antitussive
(Cough Suppressant)
Pseudoephedrine HCl, USP 60 mg Nasal Decongestant

Uses

temporarily relieves runny nose, sneezing, itching of the nose or throat, itchy watery eyes and nasal congestion due to common cold, hay fever or other upper respiratory allergies (allergic rhinitis). Temporarily relieves stuffy nose and cough due to minor throat and bronchial irritation as may occur with inhaled irritants and helps you cough less.

Warnings

Do not exceed recommended dosage.

Do not use this product

  • 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.

Do not take this product, unless directed by a doctor before use if you have

  • a persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma
  • a cough that occurs with too much phlegm (mucus)
  • heart disease, diabetes, high blood pressure or thyroid disease
  • difficulty in urination due to enlargement of the prostate gland.

Ask a doctor before use if you are
taking sedatives or tranquilizers.

When using the product

  • may cause marked drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • may cause excitability especially in children.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not improve within 7 days or are accompanied by a fever
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.

If pregnant or breastfeeding, ask a health professional before use.

Keep this and other drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Pseudoephedrine is banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over: 1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls in a 24 hour period
Children 6 to under 12 years of age: ½ teaspoonful (2.5 mL) every 6 hours, not to exceed 2 teaspoonfuls in a 24 hour period
Children under 6 years of age: Consult a doctor

Other information

Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). See USP Controlled Room Temperature. Protect from freezing. All substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Inactive ingredients

Glycerin, Propylene Glycol, Purified Water, Raspberry Flavor, Saccharin Sodium, Sorbitol.

Questions or comments?

Call 1-800-367-3395

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Manufactured For
Breckenridge
Pharmaceutical, Inc.

NDC 51991-347-16

Bromphenex™ DM

Antihistamine/Antitussive
Nasal Decongestant

SUGAR FREE ∙ ALCOHOL FREE
DYE FREE ∙ GLUTEN FREE

Each 5 mL (one teaspoonful) for
oral administration contains:

Brompheniramine Maleate, USP 4 mg
Dextromethorphan HBr, USP 30 mg
Pseudoephedrine HCI, USP 60 mg

DO NOT USE IF FOIL SEAL UNDER
CAP IS BROKEN OR MISSING

Net Contents:
16 fl. oz. (1 pint) 473 mL

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

BROMPHENEX  DM
pseudoephedrine hydrochloride, dextromethorphan hydrobromide and brompheniramine maleate liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51991-347
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 60 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 30 mg  in 5 mL
Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate 4 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin  
Propylene Glycol  
Water  
Sorbitol  
Saccharin Sodium  
Product Characteristics
Color      Score     
Shape Size
Flavor RASPBERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51991-347-16 473 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/01/2009

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Deltex Pharmaceuticals 019851778 MANUFACTURE

Revised: 11/2010 Breckenridge Pharmaceutical, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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