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Brontuss SF-NR

Dosage form: liquid
Ingredients: Dextromethorphan Hydrobromide 15mg in 5mL, Guaifenesin 300mg in 5mL, Phenylephrine Hydrochloride 10mg in 5mL
Labeler: Portal Pharmaceutical
NDC Code: 49963-381

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.

Brontuss SF-NR

Drug FactsActive ingredients
(in each 5 mL teaspoonful)
Dextromethorphan Hydrobromide 15 mg
Guaifenesin 300 mg
Phenylephrine Hydrochloride 10 mg

PurposeAntitussive
Expectorant
Nasal Decongestant

UsesTemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • helps phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • 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 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.  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 right away.

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 24
hours.
Children 6 to
under 12
years of age:

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



Other information
  • Each 5 mL teaspoonful contains 5 mg sodium.
  • Store at 59°-86° F (15°-30° C)

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

Questions? Comments?Call your doctor for medical advice 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)
portalpharmaceutical@gmail.com

Manufactured for:
Portal Pharmaceutical
Mayaguez, PR  00681

Rev. 11/11

Product PackagingThe packaging below represents the labeling currently used.

Principal display panel and side panel for 30 mL label:

NDC 49963-381-01

Brontuss
SF-NR
Liquid

· Antitussive · Expectorant
· Nasal Decongestant

Each teaspoonful (5 mL) for
oral administration contains:

Dextromethorphan HBr....................15 mg
Guaifenesin..................................300 mg
Phenylephrine HCl..........................10 mg

Grape Flavor
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. 11/11

Professional Sample:  Not For Sale






BRONTUSS  SF-NR
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49963-381
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide15 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin300 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate 
Glycerin 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49963-381-0130 mL in 1 BOTTLE
2NDC:49963-381-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/22/2011
Labeler - Portal Pharmaceutical (831005199)
Registrant - Great Southern Laboratories (056139553)
Establishment
NameAddressID/FEIOperations
Great Southern Laboratories056139553manufacture

Revised: 12/2011
 
Portal Pharmaceutical

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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