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Brontuss

Portal Inc.

Brontuss SF Liquid


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts


Active ingredients Purpose
(in each 5 mL teaspoonful)



Brontuss Uses


  • 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,


Keep out of the reach of children.


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


Questions? Comments?







Manufactured for:

Product Packaging:







Brontuss SF Liquid



Each teaspoonful (5 mL) for
oral administration contains:




Dye Free/Sugar Free/Alcohol Free







Manufactured for:
PORTAL Pharmaceutical
Mayaguez, PR  00680                    









Brontuss SF Liquid



Each teaspoonful (5 mL) for
oral administration contains:




Dye Free/Sugar Free/Alcohol Free







Manufactured for:
PORTAL Pharmaceutical
Mayaguez, PR  00680




Brontuss

Brontuss















Brontuss

Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label 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 15 mg
Guaifenesin GUAIFENESIN 300 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-03-16


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Be sure to consult your doctor before taking any medication!
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