Label: CHILDRENS GILTUSS HONEY COUGH AND CHEST CONGESTION- dextromethorphan hbr, guaifenesin solution

  • NDC Code(s): 65852-003-04
  • Packager: Dextrum Laboratories, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 24, 2025

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

  • Active Ingredients

    Active Ingredients ( in Each 5 ml) Purposes

    Dextromethorphan HBr, 10 mg ------------------------Cough Suppresant

    Guaifenesin, 100 mg --------------------------------------Expectorant Active ingredients

  • Uses

    Uses

    Uses

    Temporary relieves:

    Cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants, the intensity of coughing , the impulse to cough to help your child get to sleep, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive Uses

  • warnings

    Warnings

    Do not use

    If your child is 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 don’t know is your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product. warning

  • Ask a doctor before use if the child has

    Warnings

    Ask a doctor before use if your child has, cough that occurs with too much phlegm (mucus) , a persistent or chronic cough as occurs with asthma. Ask a doctor

  • Stop use

    Stop use and ask a doctor if

    cough lasts for more than 7 days , come back, or is accompanied by fever, rash or persistent headache. These could be signs of serious condition. Stop use

  • Keep out of reach of children

    Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately

    Keep out of reach of children

  • Directions

    Directions

    Do not take more than 6 doses in any 24 hours period

    use enclosed dosing cup

    Keep dosage cup for use with this product

    ml= milliliters

    children under 4 years of age Consult a doctor

    children 4 to under 6 years of age 2.5 ml every 4 hours

    children 6 to under 12 years of age 5 ml every 4 hours

    Adults and children 12 years & over 10 ml every 4 hours

    Directions

  • Other information

    Other information

    Store at room temperature 15-30 °C (59° -86 ° F)
    Close cap tightly
    SAVE CARTON FOR COMPLETE DRUG FACTS Other information

  • Inactive ingredients

    Inactive ingredients

    Carboxymethylcellulose sodium, citric acid, glycerin, natural and artificial flavor, natural grade A honey, methylparaben, propylene glycol, propylparaben, purified water,sucralose Inactive ingredients

  • Questions or comments?

    Questions or comments?

    Call 1-787-848-9114, Monday-Friday 9AM – 5PM EST

    Call your doctor for medical advice in the event of side effects. Questions

  • Indication and usage section

    Indication and usage section

    Do not take more than 6 doses in any 24 hours period

    use enclosed dosing cup

    Keep dosage cup for use with this product

    ml= milliliters

    children under 4 years of age Consult a doctor

    children 4 to under 6 years of age 2.5 ml every 4 hours

    children 6 to under 12 years of age 5 ml every 4 hours

    Adults and children 12 years & over 10 ml every 4 hours

    indication and usage

  • PRINCIPAL DISPLAY PANEL

    Principal panelChildren 4-12

    Alcohol free, Dye free, Non-drowsy

    True source certified honey

    Children's Giltuss Honey

    Cough & Chest Congestion

    Cough & cold, chest congestion, liquifies and loosen phlegm and mucus

    Honey lemon flavor

    4 floz 118 ml

  • INGREDIENTS AND APPEARANCE
    CHILDRENS GILTUSS HONEY COUGH AND CHEST CONGESTION 
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65852-003
    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 (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    HONEY (UNII: Y9H1V576FH)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorHONEY (Lemon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65852-003-041 in 1 CARTON06/22/2020
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/22/2020
    Labeler - Dextrum Laboratories, Inc (007392322)