BROVEX PSB- pseudoephedrine hydrochloride and brompheniramine maleate liquid

BroveX PSB by

Drug Labeling and Warnings

BroveX PSB 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
Pseudoephedrine HCl 20 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
• 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
• 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
• If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
• 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 to 6 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 to 6 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

Citric Acid, Cotton Candy Flavor, 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: 58605-150-01

BrōveX™PSB
LIQUID

Antihistamine Decongestant

Sugar Free Alcohol Free Dye Free Gluten Free

Each teaspoonful (5 mL) for oral administration contains:
Brompheniramine Maleate	4 mg
Pseudoephedrine HCl	20 mg

Cotton Candy 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 PSB 
pseudoephedrine hydrochloride and brompheniramine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58605-150
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine Hydrochloride	20 mg  in 5 mL
Brompheniramine Maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN)	Brompheniramine Maleate	4 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	COTTON CANDY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58605-150-01	473 mL in 1 BOTTLE, PLASTIC
2	NDC: 58605-150-02	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