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

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

Drug Label Information

Updated November 13, 2023

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  • ACTIVE INGREDIENT

    Active ingredient (per 5ml teaspoonful)

    Dextromethorphan HBr, USP, 10 mg

    Guaifenesin, USP 100 mg

  • PURPOSE

    Purpose

    Cough suppressant

    Expectorant

  • INDICATIONS & USAGE

    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

    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 a 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. 

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

  • DOSAGE & ADMINISTRATION

    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 teaspoonfuls (10 mL)

     Children under 12 years

     do not use
  • INACTIVE INGREDIENT

    Inactive ingredients: Cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben, water, sodium citrate, sucralose, sucrose.

  • Other Information

    •
    Each teaspoonful (5 mL) contains: sodium 2 mg
    •
    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

  • SPL UNCLASSIFIED SECTION

    Distributed By:

    MAJOR® PHARMACEUTICAL

    Livonia, MI 48152

    Refer to package label for Distributor's NDC Number

  • PRINCIPAL DISPLAY PANEL

    Guaifenesin Dextromethorphan Oral Solution

    100 mg/10 mg per 5mL

    Delivers 5 mL

    Lid 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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