Label: NIGHTTIME SLEEP-AID- diphenhydramine hcl liquid

  • NDC Code(s): 83324-015-06
  • Packager: Chain Drug Marketing Association Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 19, 2024

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  • ACTIVE INGREDIENT (in each 30mL)

    Diphenhydramine HCl 50 mg

  • PURPOSE

    Nighttime sleep-aid

  • USE(S)

    • for relief of occasional sleeplessness
    • helps you to fall asleep if you have difficulty falling asleep
  • WARNINGS

    .

  • DO NOT USE

    • for children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin
    • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
  • ASK A DOCTOR BEFORE USE IF YOU HAVE

    • a breathing problem such as emphysema, or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • heart disease

  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

    taking sedatives or tranquilizers or any other sleep-aid.

  • WHEN USING THIS PRODUCT

    • avoid alcoholic beverages and other drugs that cause drowsiness
    • drowsiness will occur
    • be careful when driving a motor vehicle or operating machinery
  • STOP USE AND ASK DOCTOR IF

    sleepleness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

  • IF PREGNANT OR BREAST-FEEDING,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    .

  • OVERDOSE WARNING

    Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • take only one dose per day (24 hours) - see Overdose warning
    • only use dosage cup that is included with this product for accurate dosing
    • mL = millilitere; Tbsp = teblespoons


      Age 
     Dose 
     adults & chlidren 12 year & over one = 30 mL (2Tbsp) at bedtime if needed or as directed by a doctor
     childrens under 12 years do not use

  • OTHER INFORMATION

    • each 30 mL (2 Tbsp) contain: sodium 30 mg
    • store at room temperature
    • protect from light
  • INACTIVE INGREDIENTS

    citric acid, FD&C Blue # 1, FD&C Red # 40, flavors, high fructose corn syrup, polyoxyl 40 stearate, purified water, saccharine sodium, sodium benzoate, sodium citrate.

  • PRINCIPAL DISPLAY PANEL

    NDC 83324-015-06

    QC® QUALITY CHOICE

    *Compare to the Active ingredient in ZzzQUIL® Nighttime Sleep Aid

    Ezz Nite Sleep Aid

    Nighttime Sleep-Aid

    Diphenhydramine HCl

    50 mg Per 30 mL


    Relieves:

    Occasional Sleeplessness


    Warming Berry Flavor

    6 FL OZ (177 ML)

    qch-633.jpg

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP-AID 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-015
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-015-06177 mL in 1 BOTTLE; Type 0: Not a Combination Product03/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGpart33803/19/2024
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(83324-015)
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