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Name:Brovex Peb
Manufacturer:Mcr American Pharmaceuticals, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


BrōveX™PEB LIQUID

BROVEX PEB - brompheniramine maleate and phenylephrine hydrochloride 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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BrōveXPEB
LIQUID

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Purpose
Brompheniramine Maleate 4 mg Antihistamine
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
  • 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 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

Rev. 03/11

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 58605-152-01

BrōveXPEB
LIQUID

AntihistamineDecongestant

Sugar Free • Alcohol Free • Dye Free • Gluten Free

Each teaspoonful (5 mL) for oral administration
contains:
Brompheniramine Maleate 4 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)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

BROVEX PEB 
brompheniramine maleate and phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58605-152
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate 4 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid Monohydrate  
Methylparaben  
Potassium Citrate  
Potassium Sorbate  
Propylparaben  
Propylene Glycol  
Water  
Sorbitol  
Sucralose  
Product Characteristics
Color      Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58605-152-01 473 mL in 1 BOTTLE, PLASTIC None
2 NDC:58605-152-02 20 mL in 1 BOTTLE, PLASTIC None

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 Operations
MCR American Pharmaceuticals, Inc. 783383011 MANUFACTURE

Revised: 04/2011 MCR American Pharmaceuticals, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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