Label: CHEST CONGESTION RELIEF DM- dextromethorphan hydrobromide, guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 16, 2024

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  • Active ingredient (per 5mL teaspoonful)

    Dextromethorphan HBr, USP 10 mg

    Guaifenesin, USP 100 mg

  • Purpose

    Cough suppressant

    Expectorant

  • Keep Out of Reach of Children

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation

    • helps loosen phlegm (mucus)

    • helps thin bronchial secretions to 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.

    Do Not Use

    if you have ever had an allergic reaction to any of the ingredients in this product.

    Ask Doctor

    before use if you have

    • a cough with too much phlegm (mucus)

    • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

    Stop Use

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

    If Pregnancy or Breast Feeding

    ask a health professional before use.

  • Directions

    Directions

    • take every 4 hours as needed, or as directed by a doctor

    • do not take more than 6 doses in 24 hours

    • do not exceed recommended dose

    Adults and children 12 years and over

    2 teaspoonsfuls (10 mL)

    Children under 12 years

    do not use
  • Other Information

    • each teaspoon (5 mL) contains: sodium 2mg

    • store at room temperature 15°-30°C (59°-86°F)

    • protect from freezing

    • do not refrigerate

    • protect from light

    • Pharmacist-Preserve and dispense in a tight, light-resistant container with a child resistant cap as defined in the USP

    • TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn broken or missing.

  • Inactive Ingredients

    cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose.

  • Questions

    or comments? 1-800-645-2158

  • This product

    is not manufactured or distributed by the owner of the registered trademark Robitussin® DM.

    THIS IS A BULK CONTAINER NOT INTENDED FOR DISPENSING.

    Distributed by:

    RUGBY LABORATORIES

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

    www.rugbylaboratories.com

    Packaged and Distributed by FOR INTITUTIONAL USE ONLY:

    MAJOR® PHARMACEUTICALS

    Indianapolis, IN 46268 USA

    Refer to package label for Distributor's NDC Number

    Rev. 08/20

    R-164

    Re-order No. 371050
  • Package/Label Principal Display Panel

    MAJOR®

    NDC 0904-7134-70

    Guaifenesin

    Dextromethorphan

    Syrup

    100 mg/10 mg per 5 mL

    Delivers 5 mL

    See insert

    For Institutional Use Only

    Alcohol Free

    Cherry Flavor

    MAJOR PHARMACEUTICALS

    Indianapolis, IN 46268

    100mg/10mg per 5mL; 5mL cup label
  • INGREDIENTS AND APPEARANCE
    CHEST CONGESTION RELIEF  DM
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7134(NDC:0536-1313)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7134-70100 in 1 CASE10/01/2020
    15 mL in 1 CUP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/01/2020
    Labeler - Major Pharmaceuticals (191427277)
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