Label: SORBUGEN- dextromethorphan hydrobromide, glycerol guaiacolate syrup

  • 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 October 15, 2022

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients (in each 7.5 mL 1½ tsp)

    Dextromethorphan HBr, 15 mg

    Glyceryl Guaiacolate (Guaifenesin), 150 mg

  • Purposes

    Antitussive

    Expectorant

  • Uses

    • for the temporary relief of cough due to minor throat and bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive
  • 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 doctor or pharmacist before taking this product.

    Ask a doctor before use if you have
    • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

    When using this product do not use more than directed.

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

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

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

  • Directions

    do not take more than 6 doses in any 24-hour period

    4 HOURS EVERYAdults and Children 12 years of age and over10 mL (2 tsp) 
    Children 6 to under 12 years of age5 mL (1 tsp)
    Children 2 to under 6 years of age2.5 mL (½ tsp)
    Children under 2 years of ageConsult physician

  • Other information

    • Tamper evident feature: Do not use if inner seal is torn, broken or missing.
    • Store at controlled room temperature 15-30°C (59-86°F).
    • Avoid excessive heat or humidity.
  • Inactive Ingredients

    Citric acid, glycerin, grape flavor, methyl paraben, potassium citrate, potassium sorbate, propyl paraben, purified water, sucralose

  • SPL UNCLASSIFIED SECTION

    Contains the same active ingredients as Sorbutuss® NR*

    Dextromethorphan HBr

    ANTITUSSIVE

    Glyceryl Guaiacolate (Guaifenesin)

    EXPECTORANT

    Antihistamine & Decongestant Free

    ​SUGAR DYE & ALCOHOL FREE

    GRAPE FLAVOR

    Manufactured in the USA for Kramer Novis. San Juan, PR 00917

    Tel: (787) 767-2072         www.kramernovis.com

    * Sorbutuss® NR is a registered trademark of Teral, Inc. This product is not manufactured, distributed or marketed by Teral, Inc.

  • Packaging

    Sorbgn

  • INGREDIENTS AND APPEARANCE
    SORBUGEN 
    dextromethorphan hydrobromide, glycerol guaiacolate syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-660
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 7.5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN150 mg  in 7.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (SWEET GRAPE) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-660-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product10/08/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/08/2014
    Labeler - Kramer Novis (090158395)
    Registrant - Kramer Novis (090158395)