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

  • 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 September 30, 2021

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

  • 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 finalpart34110/01/2020
    Labeler - Major Pharmaceuticals (191427277)