Label: DRKIDS CHILDRENS COUGH AND CHEST CONGESTION DM- dextromethorphan hydrobromide, guaifenesin solution

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

Drug Label Information

Updated December 15, 2023

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

View All Sections
  • Active Ingredient (in each 5mL)

    Dextromethorphan HBr, USP, 5mg

    Guaifenesin, USP, 100mg

    Purpose

    Cough suppressant

    Expectorant

  • Uses

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

    Do not use

    if your child is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if your child has

    persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor if

    cough lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

    Keep out of reach of children

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

  • Directions

    do not give more than 6 doses in any 24 hour period
    give the recommended number of vials below, following the instructions under How to Open and Use on the side panel
    empty all liquid in each Single-Use Vial when dosing

    Dosing Chart

    Age (Years) Dose
    under 4 yearsConsult a doctor
    4 – 5 years 1 Single-Use Vial (5 mL) every 4 hours
    6 – 11 years 1 – 2 Single-Use Vials (5 mL each) every 4 hours
    Adults and children 12 years and over 2 – 4 Single-Use Vials (5 mL each) every 4 hours



  • Inactive Ingredients

    citric acid, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

  • Other information

    • each Single-Use vial contains 6mg of sodium
    • store at 20-25ºC (68-77ºF)
    • tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken
  • Questions or comments?

    941-202-3270 or visit www.DrKids.com

  • Package

    PDP

  • INGREDIENTS AND APPEARANCE
    DRKIDS CHILDRENS COUGH AND CHEST CONGESTION DM 
    dextromethorphan hydrobromide, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-0013
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73282-0013-120 in 1 CARTON12/15/2023
    15 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/15/2023
    Labeler - CalmCo LLC (079308308)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!