Label: DAYTIME COUGH CONGESTION NIGHTTIME COLD COUGH- dextromethorphan hbr, guaifenesin, diphenhydramine hcl kit

  • NDC Code(s): 82673-102-04, 82673-191-04, 82673-901-08
  • Packager: KinderFarms, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 12, 2024

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

  • Active ingredient Daytime (in each 5 mL)

    Dextromethorphan HBr USP, 5 mg

    Guaifenesin USP, 100 mg

  • Active ingredient Nighttime (in each 5 mL)

    Diphenhydramine HCl 12.5 mg

  • Purposes for Day Time

    Cough suppressant

    Expectorant

  • Purposes for Night Time

    Antihistamine/Cough suppressant

  • Uses

    Daytime

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves
      • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
      • the intensity of coughing
      • the impulse to cough to help your child get to sleep

    Nighttime

    • temporarily relieves:
      • sneezing
      • runny nose
      • itching of the nose or throat
      • itchy, watery eyes due to hay fever or other upper respiratory allergies
      • the impulse to cough
      • cough to help you get to sleep
      • cough due to minor throat and bronchial irritation as may occur with cold or inhaled irritants
      • the intensity of coughing
  • Warnings

    Do not use

    DAYTIME

    in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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 childs prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    NIGHTTIME

    • in a child under 4 years of age
    • with any other product containing diphenhydramine even one used on the skin
    • for the purpose of making your child sleepy

    Ask a doctor before use your child has

    DAYTIME

    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such occurs with asthma

    NIGHTTIME

    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occur with smoking, asthma, or emphysema
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if the child is

    NIGHTTIME

    taking sedatives or tranquilizers.

    When using this product

    Nighttime

    • do not exceed recommended dosage
    • marked drowsiness may occur
    • excitability may occur, especially in children
    • alcohol, sedatives and tranquilizers may increase the drowsiness effect
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    DAYTIME

    cough lasts more than 7 days, comes back, or occurs with a fever, rash, or headache that lasts.These could be signs of a serious condition.

    NIGHTTIME

    cough persists for more than 1 weeks, tend to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    Daytime

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

    Nighttime

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

  • Directions

    Daytime

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • mL = milliliter
    • shake well before using
    agedose
     children 6 to under 12 years 5-10 mL every 4 hours
     children 4 to under 6 years2.5-5 mL every 4 hours
     children under 4 yearsdo not use


    Nighttime

    • adults and children 6 years and over: do not exceed more than 6 doses in 24 hour unless directed by a doctor
    • measure only with dosing cup provided. Do not use any other dosing device
    • keep dosing cup with product
    • shake well before using
    • mL = milliliter
    Age
    Dose
    adults and children 12 years of age and over
    10 mL every 4 hours
     children 6 to under 12 years of age
     5 mL every 4 hours
    children 4 to under 6 years of age
    do not use unless directed by a doctor
     children under 4 years of age
     do not use

  • Other information

    Daytime

    • store between 20-25ºC (68º-77ºF).
    • Do not refrigerate.

    Nighttime

    • store between 20-25ºC (68-77ºF).
    • Do not refrigerate
    • protect from light
  • Inactive ingredients

    Day Time

    Organic agave syrup, non-GMO citric acid, glycerin, organic natural flavors, purified water

    Night Time

    Organic agave syrup, non-GMO citric acid, organic natural flavors, purified water

  • Questions or comments?

    Call 424-235-0355

  • Principal Display Panel

    Same active ingredients as Mucinex Children's® Cough†

    KIDS' COUGH & CONGESTION  Ages 4-11 yrs

    Dextromethorphan HBr 5 mg per 5 mL

    Cough Suppressant

    Guaifenesin 100 mg per 5 mL

    Expectorant

    Organic Berry Flavor

    DOSING CUP INCLUDED

    FL OZ (mL)

    keep outer carton for complete warnings and product information

    KIDS'  Ages 6+

    NIGHTTIME

    COLD & COUGH

    Diphenhydramine HCl 12.5 mg per 5 mL

    Antihistamine/Cough Suppressant

    Organic Cherry Flavor

    DOSING CUP INCLUDED

    fl oz (mL)

    DO NOT TAKE KIDS' COUGH & CONGESTION AND KIDS' NIGHTTIME COLD & COUGH AT THE SAME TIME.

    TAMPER EVIDENT: BOTTLE IS SAFETY SEALED WITH A PERFORATED BAND AROUND BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

    .†THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY RB HEALTH (US) LLC, DISTRIBUTOR OF MUCINEX CHILDREN'S® COUGH

    DISTRIBUTED BY: KinderFarm®

    Redondo Beach, CA 90277

     


  • Product Label

    Dextromethorphan HBr USP, 5 mg Guaifenesin USP, 100 mg Diphenhydramine HCl 12.5 mg

    KINDERMED Kids Cough & Congestion Kids Nighttime Cold & Cough

  • INGREDIENTS AND APPEARANCE
    DAYTIME COUGH CONGESTION NIGHTTIME COLD COUGH 
    dextromethorphan hbr, guaifenesin, diphenhydramine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82673-901
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82673-901-081 in 1 KIT; Type 0: Not a Combination Product05/30/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 118 mL
    Part 21 BOTTLE, PLASTIC 118 mL
    Part 1 of 2
    MUCUS RELIEF COUGH AND CONGESTION  CHILDRENS
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Item Code (Source)NDC:82673-102
    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
    AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82673-102-041 in 1 BOX
    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 DrugM01205/30/2024
    Part 2 of 2
    NIGHTTIME COLD AND COUGH 
    diphenhydramine hcl liquid
    Product Information
    Item Code (Source)NDC:82673-191
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82673-191-041 in 1 BOX
    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 DrugM01205/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/30/2024
    Labeler - KinderFarms, LLC (075458767)