BROVEX PEB DM- brompheniramine maleate, phenylephrine hydrochloride, and dextromethorphan hydrobromide liquid

BroveX PEB DM by

Drug Labeling and Warnings

BroveX PEB DM by is a Otc medication manufactured, distributed, or labeled by MCR American Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 mL teaspoonful)	Purpose
Brompheniramine Maleate 4 mg	Antihistamine
Dextromethorphan HBr 20 mg	Cough Suppressant
Phenylephrine HCl 10 mg	Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• cough due to minor throat and bronchial irritation
• nasal congestion
• reduces swelling of nasal passages

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

Ask a doctor before use if you have

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

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

• excitability may occur, especially in children
• may cause drowsiness
• sedatives and tranquilizers may increase drowsiness
• avoid alcoholic beverages
• use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
• new symptoms occur

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

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately. 1-800-222-1222

Directions

Do not exceed recommended dosage.

• Adults and children 12 years of age and over: 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor
• Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 4 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor
• Children under 6 years of age: Consult a doctor

Other information

Store at 20°-25°C (68°-77°F); excursions permitted to 15°- 30°C (59°-86°F) [see USP Controlled Room Temperature].

Inactive ingredients

Bubblegum Flavor, Citric Acid, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose

Question? Comments?

Call 1-800-793-2145

SPL UNCLASSIFIED SECTION

Rev. 03/11

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC: 58605-153-01

BrōveX™PEB DM
LIQUID

Antihistamine Cough Suppressant Decongestant

Sugar Free Alcohol Free Dye Free Gluten Free

Each teaspoonful (5 mL) for oral administration contains:
Brompheniramine Maleate	4 mg
Dextromethorphan HBr	20 mg
Phenylephrine HCl	10 mg

Bubblegum Flavor

This bottle is not to be dispensed to consumer.

Tamper evident by foil seal under cap. Do not use if
foil seal is broken or missing.

Dispense in a tight container with a child-resistant
cap.

Manufactured for:
PERNIX
THERAPEUTICS
Gonzales, LA 70737

16 fl oz (473 mL)

INGREDIENTS AND APPEARANCE

BROVEX PEB DM 
brompheniramine maleate, phenylephrine hydrochloride, and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58605-153
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Brompheniramine Maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN)	Brompheniramine Maleate	4 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	10 mg  in 5 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	20 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Methylparaben (UNII: A2I8C7HI9T)
Potassium Citrate (UNII: EE90ONI6FF)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Propylparaben (UNII: Z8IX2SC1OH)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
Sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58605-153-01	473 mL in 1 BOTTLE, PLASTIC
2	NDC: 58605-153-02	20 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	11/30/2007

Labeler - MCR American Pharmaceuticals, Inc. (783383011)

Establishment
Name	Address	ID/FEI	Business Operations
MCR American Pharmaceuticals, Inc.		783383011	MANUFACTURE