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

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Bromphenex™ DM

Active ingredients	Purpose
Dextromethorphan HBr, USP 30 mg.............................................	Antitussive
Pseudoephedrine HCl, USP 60 mg...............................................	Decongestant
Brompheniramine Maleate, USP 4 mg...........................................	Antihistamine

in each teaspoonful (5 mL) clear fruit-flavored liquid.

Uses

• temporarily relieves coughs and upper respiratory symptoms, involving nasal congestion, associated with allergy or the common cold.

Warnings

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor.

Do not use

• in a child under 12 years of age
• 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 two 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 drug.

Do not use this product before checking with your doctor or pharmacist, if you have any of the following conditions:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• asthma
• glaucoma
• gastrointestinal obstruction
• trouble urinating due to enlarged prostate gland
• breathing problems such as emphysema or chronic bronchitis.

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

When using this product

• do not use more than directed
• marked drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop using this medicine and ask your doctor if you experience

• nervousness, dizziness or sleeplessness symptoms
• symptoms do not improve or are accompanied by fever, rash or persistent headache. These could be sign of a serious condition.

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

Stimulants, such as pseudoephedrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Directions

Adults and children over 12 years of age	One teaspoonful (5 mL) every 6 hours.
Children under 12 years of age	Not indicated

Do not exceed 4 doses in a 24 hour period

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.

• Sugar Free
• Alcohol Free
• Dye Free

Inactive ingredients

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

Questions? Comments?

Call at 1-800-367-3395

Distributed by:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Manufactured by:
Deltex Pharmaceuticals
Rosenberg, TX 77471

Rev. 02/09

PRINCIPAL DISPLAY PANEL - 473 mL Bottle

Breckenridge
Pharmaceutical, Inc.

NDC 51991-347-16

Bromphenex™ DM

Antitussive • Decongestant
Antihistamine

SUGAR FREE • ALCOHOL FREE
DYE FREE

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

16 fl. oz. (One Pint) 473 mL

BROMPHENEX  DM pseudoephedrine hydrochloride, dextromethorphan hydrobromide and brompheniramine maleate   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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 Sorbitol   Glycerin   Propylene Glycol   Saccharin Sodium   Water

Product Characteristics Color      Score      Shape Size Flavor FRUIT Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 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
Unapproved other		03/01/2009

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
Deltex Pharmaceuticals		019851778	MANUFACTURE

Revised: 10/2009Breckenridge Pharmaceutical, Inc.