BroveX PSB description, usages, side effects, indications, overdosage, supplying and lots more!

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BroveX PSB

MCR American Pharmaceuticals, Inc.

BrōveXPSB LIQUID


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients
(in each 5 mL teaspoonful)
Purpose
Brompheniramine Maleate 4 mg Antihistamine
Pseudoephedrine HCl 20 mg Decongestant

BroveX PSB 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

BroveX PSB 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 58605-150-01

BrōveX PSB
LIQUID

AntihistamineDecongestant

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)

BroveX PSB

BroveX PSB

Pseudoephedrine Hydrochloride and Brompheniramine Maleate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58605-150
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pseudoephedrine Hydrochloride Pseudoephedrine 20 mg
Brompheniramine Maleate BROMPHENIRAMINE 4 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
METHYLPARABEN
POTASSIUM CITRATE
POTASSIUM SORBATE
PROPYLPARABEN
propylene glycol
water
sorbitol
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58605-150-01 473 in 1 BOTTLE, PLASTIC
2 NDC:58605-150-02 20 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-11-30


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Be sure to consult your doctor before taking any medication!
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