Label: BRONTUSS DX- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 49963-913-04, 49963-913-15 - Packager: Portal Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 17, 2009
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
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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 loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- nasal congestion
- reduces swelling of nasal passages
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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 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
- 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
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Directions
Do not exceed recommended dosage.
Adults and Children 12 years of age and older:
2 teaspoonfuls (10mL) every 6 hours, not to exceed 4 doses in a 24 hour period.
Children 6 to under 12 years of age:
1 teaspoonful (5 mL) every 6 hours, not to exceed 4 doses in a 24 hour period.
Children under 6 years of age:
Not recommended for use.
- Other information
- Inactive ingredients
- Questions? Comments?
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PRODUCT PACKAGING:
The packaging below represents the labeling currently used:
Principal Display Panel and Side Panel for 118mL Label:
NDC 49963-913-04
Brontuss
DX
Antitussive / Expectorant
Decongestant
Each teaspoonful (5 mL) for oral administration contains:
Dextromethorphan HBr.............. 20 mg
Guaifenesin.............................200 mg
Phenylephrine HCl.................... 10 mg
Dye Free - Sugar Free
Alcohol Free - Gluten 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. 10/09
Principal Display Panel and Side Panel for 15 mL Label:
NDC 49963-913-15
Brontuss
DX
Antitussive / Expectorant
Decongestant
Each teaspoonful (5 mL) for oral administration contains:
Dextromethorphan HBr.......... 20 mg
Guaifenesin........................ 200 mg
Phenylephrine HCl................ 10 mg
Dye Free / Sugar Free
Alcohol Free / Gluten Free
15 mL (1/2 fl oz)
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.
Professional Sample:
Not For Sale
Manufactured for:
Portal Pharmaceutical
Mayaguez, PR 00680
Rev. 10/09
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INGREDIENTS AND APPEARANCE
BRONTUSS DX
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49963-913 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 20 mg in 5 mL Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 200 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 CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49963-913-04 118 mL in 1 BOTTLE 2 NDC:49963-913-15 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/24/2009 Labeler - Portal Inc. (831005199)