BRONTUSS- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Brontuss by

Drug Labeling and Warnings

Brontuss by is a Otc medication manufactured, distributed, or labeled by Portal Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 ofage 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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	15 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	300 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	10 mg  in 5 mL

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49963-813-04	118 mL in 1 BOTTLE
2	NDC: 49963-813-01	30 mL in 1 BOTTLE

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)