Label: BRONTUSS SF-NR- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 49963-381-01, 49963-381-04 - Packager: Portal Pharmaceutical
- 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 14, 2011
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 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 24
hours.
Children 6 to
under 12
years of age:
1/2 teaspoonful (2.5 mL)
every 4 hours, not to
exceed 6 doses in 24
hours.
Children
under 6 years
of age:
Consult a doctor.
- Other information
- Inactive ingredients
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Questions? Comments?
Call your doctor for medical advice 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)
portalpharmaceutical@gmail.com
Manufactured for:
Portal Pharmaceutical
Mayaguez, PR 00681
Rev. 11/11
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Product Packaging
The packaging below represents the labeling currently used.
Principal display panel and side panel for 30 mL label:
NDC 49963-381-01
Brontuss
SF-NR
Liquid
· Antitussive · Expectorant
· Nasal Decongestant
Each teaspoonful (5 mL) for
oral administration contains:
Dextromethorphan HBr....................15 mg
Guaifenesin..................................300 mg
Phenylephrine HCl..........................10 mg
Grape Flavor
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. 11/11
Professional Sample: Not For Sale
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INGREDIENTS AND APPEARANCE
BRONTUSS SF-NR
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49963-381 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 Inactive Ingredients Ingredient Name Strength Citric Acid Monohydrate (UNII: 2968PHW8QP) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Sodium Citrate (UNII: 1Q73Q2JULR) Saccharin Sodium (UNII: SB8ZUX40TY) Sorbitol (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49963-381-01 30 mL in 1 BOTTLE 2 NDC:49963-381-04 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/22/2011 Labeler - Portal Pharmaceutical (831005199) Registrant - Great Southern Laboratories (056139553) Establishment Name Address ID/FEI Business Operations Great Southern Laboratories 056139553 manufacture