BROVEX PSB DM- pseudoephedrine hydrochloride, brompheniramine maleate, and dextromethorphan hydrobromide liquid 
MCR American Pharmaceuticals, 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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BrōveX™PSB DM
LIQUID

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)		Purpose
Brompheniramine Maleate 4 mgAntihistamine
Dextromethorphan HBr 20 mgCough Suppressant
Pseudoephedrine HCl 20 mgDecongestant

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

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

Rev. 03/11

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 58605-151-01

BrōveX™PSB DM
LIQUID

Antihistamine • Cough Suppressant • Decongestant

Sugar Free • Alcohol Free • Dye Free • Gluten Free

Each teaspoonful (5 mL) for oral administration
contains:
Brompheniramine Maleate4 mg
Dextromethorphan HBr20 mg
Pseudoephedrine HCl20 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)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
BROVEX PSB DM 
pseudoephedrine hydrochloride, brompheniramine maleate, and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58605-151
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride20 mg  in 5 mL
Brompheniramine Maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN) Brompheniramine Maleate4 mg  in 5 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide20 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58605-151-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/30/200710/31/2013
2NDC:58605-151-0220 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/30/200710/31/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/30/200710/31/2013
Labeler - MCR American Pharmaceuticals, Inc. (783383011)

Revised: 5/2020
Document Id: 7d04ab4b-428b-48e3-81be-99ce00480de6
Set id: 5a6f21f8-651f-4559-98d8-bb2646a216ca
Version: 2
Effective Time: 20200521
 
MCR American Pharmaceuticals, Inc.