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Name:Brontuss
Manufacturer:Portal Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


Brontuss Tablets

BRONTUSS  - dextromethorphan hydrobromide and guaifenesin tablet 
Portal Pharmaceuticals

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Brontuss Tablets

Drug Facts

Active ingredients (in each tablet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purpose

Dextromethorphan HBr - Cough suppressant

Guaifenesin - Expectorant

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.
  • Helps make coughs more productive.

Warnings

Do not use

  • 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

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

  • Symptoms are accompanied by fever, rash or persistent headache.
  • Cough persists for more than 1 week or tends to recur.

A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

  • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed.
  • Children under 12 years of age: do not use.
  • Do not exceed 6 doses in a 24 hour period or as directed by a doctor.

Other information

store at 20°- 25°C (68°- 77°F)

Inactive ingredients

Calcium phosphate dibasic, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium starch glycolate

Questions?

Call (787) 832-6645
portalpharmaceutical@gmail.com
Operation Hours: Monday – Friday 8 A.M. – 4 P.M.

Distributed by:
Portal Pharmaceutical

Mayaguez, Puerto Rico, 00680

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49963-126-01

20 mg dextromethorphan HBr & 400 mg guaifenesin tablets

COUGH SUPPRESSANT & EXPECTORANT

Controls Cough

Thins and Loosens Mucus

787f2906-figure-01

Figure 1: Container label


BRONTUSS 
dextromethorphan hydrobromide / guaifenesin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49963-126
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 20 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE  
MAGNESIUM STEARATE  
POVIDONE K30  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
CELLULOSE, MICROCRYSTALLINE  
SILICON DIOXIDE  
Product Characteristics
Color WHITE Score 2 pieces
Shape CAPSULE Size 19mm
Flavor Imprint Code BRS
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49963-126-01 100 TABLET ( TABLET) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/03/2010

Labeler - Portal Pharmaceuticals (831005199)
Registrant - Portal Pharmaceutical (831005199)
Establishment
Name Address ID/FEI Operations
Sovereign Pharmaceuticals, LLC 623168267 MANUFACTURE

Revised: 01/2010 Portal Pharmaceuticals



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


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