BRONTUSS  SF- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid 
Portal 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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Brontuss SF Liquid

Drug Facts


Active ingredients                                              Purpose
(in each 5 mL teaspoonful)
Dextromethorphan Hydrobromide 15 mg..................Antitussive
Guaifenesin 300 mg...............................................Expectorant
Phenylephrine Hydrochloride 10 mg.........................Nasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

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 cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

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

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 doses in a 24 hour period.
Children 6 to under 12 years of
age:
1/2 teaspoonful (2.5 mL) every 4 hours, not to
exceed 6 doses in a 24 hour period.
Children under 6 years of age:
Consult a doctor

Other Information

Inactive Ingredients

citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

Questions? Comments?

Call your doctor for medical advise about side effects.  Serious side effects associated with this product
may be reported to this number.
Call (787) 832-6645
Operation Hours:  Monday-Friday, 8 A.M. to 4 P.M.
Atlantic Standard Time (AST)

Manufactured for: Portal Pharmaceuticals, Mayaguez, PR  00680
portalpharmaceutical@gmail.com                                Rev. 02/10

Product Packaging:

Packaging below represents the labeling currently used:

Principal display panel and side panel for 30 mL label:

NDC 49963-813-01

Brontuss SF Liquid

Antitussive/Expectorant/Nasal Decongestant

Each teaspoonful (5 mL) for
oral administration contains:
Dextromethorphan HBr.........................15 mg
Guaifenesin.......................................300 mg
Phenylephrine HCl...............................10 mg

Dye Free/Sugar Free/Alcohol Free

1 oz. (30 mL)

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Supplied in a tight, light-resistant container with a child-resistant cap.

Manufactured for:
PORTAL Pharmaceutical
Mayaguez, PR  00680                    
Rev. 02/10




Principal display panel and side panel for 118 mL label:

NDC 49963-813-04

Brontuss SF Liquid

Antitussive/Expectorant/Nasal Decongestant

Each teaspoonful (5 mL) for
oral administration contains:
Dextromethorphan HBr..........................15 mg
Guaifenesin........................................300 mg
Phenylephrine HCl................................10 mg

Dye Free/Sugar Free/Alcohol Free

4 oz. (118 mL)

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Supplied in a tight, light-resistant container with a child resistant cap.

Manufactured for:
PORTAL Pharmaceutical
Mayaguez, PR  00680

Rev. 02/10


Brontuss SF Packaging


Brontuss SF Packaging
















BRONTUSS   SF
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49963-813
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide15 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin300 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg  in 5 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49963-813-04118 mL in 1 BOTTLE
2NDC:49963-813-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/16/2010
Labeler - Portal Inc. (831005199)

Revised: 5/2010
Document Id: e1f6b972-4786-4c51-aaf8-181d6da0f5e8
Set id: 4f816062-aaf6-4526-8269-2671c88cab1e
Version: 1
Effective Time: 20100512
 
Portal Inc.