Label: BRONTUSS SF-NR- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL

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

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  • Drug Facts

    Active ingredients
    (in each 5 mL teaspoonful)
    Dextromethorphan Hydrobromide 15 mg
    Guaifenesin 300 mg
    Phenylephrine Hydrochloride 10 mg

    Purpose

    Antitussive
    Expectorant
    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 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.  A persistent cough may be a sign of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.
  • 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

    • Each 5 mL teaspoonful contains 5 mg sodium.
    • Store at 59°-86° F (15°-30° C)
  • Inactive ingredients

    citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.
  • 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
  • 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

    Brontuss SF-NR Packaging


    Brontuss SF-NR Packaging



  • INGREDIENTS AND APPEARANCE
    BRONTUSS  SF-NR
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49963-381
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide15 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin300 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49963-381-0130 mL in 1 BOTTLE
    2NDC:49963-381-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/22/2011
    Labeler - Portal Pharmaceutical (831005199)
    Registrant - Great Southern Laboratories (056139553)
    Establishment
    NameAddressID/FEIBusiness Operations
    Great Southern Laboratories056139553manufacture
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