Label: VICKS CHILDRENS COUGH CONGESTION NIGHT- phenylephrine hydrochloride and diphenhydramine hydrochloride liquid

  • NDC Code(s): 37000-712-06
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each 15 mL)

    Diphenhydramine HCl 12.5 mg

    Phenylephrine HCl 5 mg

    Purpose

    Antihistamine/Cough suppressant
    Nasal decongestant

  • Uses

    temporarily relieves common cold symptoms:

    • nasal congestion
    • runny nose & sneezing
    • cough due to minor throat and bronchial irritation
  • Warnings

    Do not use

    • with any other product containing diphenhydramine, even one used on skin
    • to make a child sleepy
    • if you are 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema
    • a sodium-restricted diet
  • Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

  • When using this product

    • do not use more than directed.
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
  • Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • 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.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Other information

    • each 15 mL contains:sodium 44 mg
    • store at no greater than 25ºC.
  • Directions

    • take only as directed
    • only use the dose cup provided
    • do not exceed 4 doses per 24 hrs
    adults & children 12 yrs & over30 mL every 4 hrs
    children 6 to under 12 yrs15 mL every 4 hrs
    children 4 to under 6 yrsdo not use unless directed by a doctor
    children under 4 yrsdo not use

  • Other information

    • each 15 mL contains:sodium 44 mg
    • store at no greater than 25ºC.
  • Inactive ingredients

    anhydrous citric acid, flavor, glycerin, polysorbate 20, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose

  • Questions?

    1-800-362-1683

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT:Do not use if printed safety seal under cap is missing or damaged.

  • SPL UNCLASSIFIED SECTION

    DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202

    Made in Canada

  • PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label

    VICKS®

    children's

    Cough

    Congestion Night

    Phenylephrine HCI - nasal decongestant
    Diphenhydramine HCI - antihistamine/cough suppressant

    FREEof:

    Artificial Dyes & Flavors,

    High Fructose Corn Syrup & Alcohol

    • Cough
    • Runny nose
    • Stuffy nose
    • Sneezing

    Ages 6+

    6 FL OZ (177 ml)

    712

  • INGREDIENTS AND APPEARANCE
    VICKS CHILDRENS  COUGH CONGESTION NIGHT
    phenylephrine hydrochloride and diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-712
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorwhite (Clear) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-712-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/22/2019
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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