Label: NIGHTTIME COLD AND COUGH CHILDRENS- 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 May 13, 2019

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 irritations 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. If you do not know if your child's prescription 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 child 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 occurs
    • symptoms do not improve within 7 days or occur with a fever
    • cough persists for more than 7 days, comes back or occurs with 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 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
    AgeDose 
    children 6 to under 12 years of age 10 mL every 4 hours
    children 4 to under 6 years of agedo not use unless directed by a doctor
    children under 4 years do not use 

  • Other Information

    • each 5 mL contains: sodium 3 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
    • protect from light
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate

  • Questions or comments?

     Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Children's

    Nighttime Cold & Cough

    DIPHENHYDRAMINE HCI Antihistamine; Cough suppressant

    PHENYLEPHRINE HCl  Nasal decongestant

    Relieves:

    • Cough
    • Runny, stuffy nose
    • Itchy throat

    Alcohol free

    For Ages 6 to 11 Years

    Grape Flavor

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    CVS.com

  • Package Label

    Diphenhydramine HCl 6.25 mg, Phenylephrine HCl 2.5 mg

    CVS HEALTH Children's Nighttime Cold & Cough

     

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COLD AND COUGH  CHILDRENS
    diphenhydramine hcl, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-379
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-379-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34104/30/2018
    Labeler - CVS Pharmacy (062312574)