BRONTUSS DX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL INC.]

  • Home
  • BRONTUSS DX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL INC.]

BRONTUSS DX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL INC.]
PDF | XML
NDC 49963-913-04, 49963-913-15
Set ID c83c41c1-e66f-4aea-82ad-2028dbf50f95
Category HUMAN OTC DRUG LABEL
Packager Portal Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
View All Sections
  • Drug Facts

    Active ingredients                             Purpose
    (in each 5 mL teaspoonful)
    Dextromethorphan Hydrobromide 20 mg...... Antitussive
    Guaifenesin 200 mg................................ Expectorant
    Phenylephrine Hydrochloride 10 mg..........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 loosen 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 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.
    • new symptoms occur

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
  • 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

    Store at 59o-86oF (15o-30oC)
  • Inactive ingredients

    cherry flavor, citric acid, maltitol, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.
  • Questions? Comments?

    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 00680

    Rev. 10/09
  • 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

    Brontuss DX Packaging

    Brontuss DX Packaging

    Brontuss DX Packaging

    Brontuss DX Packaging

  • INGREDIENTS AND APPEARANCE
    BRONTUSS  DX
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49963-913
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide20 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg  in 5 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49963-913-04118 mL in 1 BOTTLE
    2NDC:49963-913-1515 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/24/2009
    Labeler - Portal Inc. (831005199)
View All Sections

Related Drugs

Search DailyMed Drugs