Label: CHILDRENS NIGHTTIME COLD AND COUGH- diphenhydramine hcl, phenylephrine hcl 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 June 5, 2023

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

  • Active ingredients (in each 5 mL)

    Diphenhydramine HCl 6.25 mg

    Phenylephrine HCl 2.5 mg

  • Purposes

    Antihistamine/

    Cough suppressant

    Nasal decongestant

  • Uses

    temporarily relieves:

    • sneezing
    • runny nose
    • itchy nose or throat
    • itchy, watery eyes due to hay fever
    • nasal and sinus congestion
    • cough due to minor throat and bronchial irritation as may occur with a cold
  • Warnings

    Do not use

    • in a child under 4 years of age
    • in a child who is 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 contains an MAOI, ask a doctor or pharmacist before giving this product.
    • with any other product containing diphenhydramine, even one used on skin
    • for the purpose of making your child sleepy

    Ask a doctor before use if the chld has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • chronic cough that lasts, or as occurs with asthma
    • a breathing problem such as chronic bronchitis

    Ask a doctor or pharmacist before use if the child is

    taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dosage
    • marked drowsiness may occur
    • excitability may occur, especially in children
    • sedatives and tranquilizers may increase drowsiness

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occur
    • symptoms do not improve within 7 days or occur with a fever
    • cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.

    These could be signs of a serious condition.

    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.

  • Directions

    • do not give more than 6 doses in any 24-hours unless directed by a doctor
    • measure only with dosing cup provided. Do not use any other dosing device
    • keep dosing cup with product
    • mL= milliliter
    • shake well before using
     age dose
    children 6 to under12 years of age
    10 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

    • store between  20-25º (68-77ºF)
    • do not refrigerate
    • protect from light
  • Inactive ingredients

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

  • QUESTIONS?

     Call 424-235-0355

  • Principal Display Panel

    KIDS NIGHTTIME COLD & COUGH Age 6-11 yrs

    Diphenhydramine HCl 6.25 mg per 5 mL

    Antihistamine/ Cough Suppressant

    Phenylephrine HCl 2.5 mg per 5 mL

    Nasal Decongestant

    Organic Cherry Flavor

    NO COMMON ALLERGENS.

    NO DYES OR PARABENS.

    DOSING CUP INCLUDED

    FL OZ (mL)

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

    Keep outer carton for complete warnings and product information.

    DISTRIBUTED BY: KinderFarms®

    Redondo Beach, CA 90277 USA

    kinderfarms.com

  • Package Label

    Diphenhydramine HCl USP, 6.25 mg, Phenylephrine HCl USP, 2.5 mg

    KINDERMED Kids Nighttime Cold & Cough Cherry Flavor

  • INGREDIENTS AND APPEARANCE
    CHILDRENS NIGHTTIME COLD AND COUGH 
    diphenhydramine hcl, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82673-103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 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:82673-103-041 in 1 BOX04/29/2022
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/29/2022
    Labeler - KinderFarms, LLC (075458767)