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Name:Brontuss Sf
Manufacturer:Portal Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Brontuss SF Liquid

BRONTUSS  SF - dextromethorphan hydrobromide, guaifenesin and 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:
  • cough due to minor throat and bronchial irritation
  • helps losen 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.  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

  • Each 5mL teaspoonful contains 5 mg sodium.
  • Store at 59o-86oF(15o-30oC)

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 Type HUMAN OTC DRUG Item Code (Source) NDC:49963-813
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 15 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin 300 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg  in 5 mL
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49963-813-04 118 mL in 1 BOTTLE None
2 NDC:49963-813-01 30 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/16/2010

Labeler - Portal Inc. (831005199)

Revised: 05/2010 Portal Inc.



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


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