Label: BRONCO SILEN-DM- dextromethorphan hydrobromide, guaifenesin solution

  • 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 November 5, 2015

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  • Active Ingredients (in each 10mL)

    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg

  • Purpose

    Cough Suppressant

    Expectorant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • Warnings

    Do not use 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 health professional before taking this product.

  • Ask a doctor before use if you have

    • cough that occurs with to much phlegm (mucus)
    • cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • STOP USE

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    agedose
    adults and children 12 years and over10 ml (2 teaspoonfuls) every 4 hours; not to exceed 6 doses (12 teaspoonfuls) in a 24 hour period.
    children 6 to under 12 years5 ml (1 teaspoonful) every 4 hours; not to exceed 6 doses (6 teaspoonfuls) in a 24 hour period.
    children under 6 yearsAsk a doctor

  • Other Information

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

    Cherry Flavor, Citric Acid, FD&C red no. 40, Hydroxyethyl Cellulose, Menthol, Methylparaben, Polyethylene Glycol, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate and Sucralose

  • Questions:

    Contact us Monday to Friday at (305) 256-1469 9:00am - 5:00pm EST.

  • Display Label

    NDC 59561-202-04
    GERMA
    BRONCO-SILEN-DM
    COUGH SUPPRESSANT
    EXPECTORANT
    Sugar FREE
    Alcohol FREE
    Non-Drowsy
    New Improved Taste
    Stronger than Leading Brands
    Contents: 4 FL. OZ. (118 mL) BRONCO SILEN-DM

  • INGREDIENTS AND APPEARANCE
    BRONCO SILEN-DM 
    dextromethorphan hydrobromide, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59561-202
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYETHYL CELLULOSE (6500 MPA.S AT 2%) (UNII: 2Q40985DRM)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorRED (Clear) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59561-202-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/05/2015
    Labeler - Caribe Natural, LLC (624210480)
    Registrant - Caribe Natural, LLC (624210480)
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