Label: BRONTUSS- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 49963-813-01, 49963-813-04 - 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 May 12, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 losen 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, 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
- 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 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
- Inactive Ingredients
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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
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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
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INGREDIENTS AND APPEARANCE
BRONTUSS SF
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct 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)