EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]

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EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]
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NDC 21130-014-06, 21130-014-12, 21130-014-24
Set ID 21a68c60-3005-43bb-8ec5-7982239c93f8
Category HUMAN OTC DRUG LABEL
Packager Safeway, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredient (in each 30 mL)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • for the relief of occasional sleeplessness
    • reduces time to fall asleep if you have difficulty falling asleep
  • Warnings

    Do not use

    • with any other product containing diphenhydramine, even one used on skin
    • for children under 12 years of age
    • with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids

    Ask a doctor before use if you have

    • breathing problem such as asthma emphysema or chronic bronchitis
    • glaucoma
    • heart disease
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers or any other sleep-aid.

    When using this product

    • drowsiness will occur
    • avoid alcoholic beverages and other drugs that cause drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    sleeplessness persists continuously for more than 2 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 (1800-222-1222).

  • Directions

    • take only one dose per day (24 hours) - (see overdose warning)
    • mL=milliliter
    • measure only with dosing cup provided. Do not use any other dosing device
    • keep dosing cup with product
    • adults and children 12 years and over
      • one dose=30mL at bedtime if needed, or as directed by a doctor
    • children under 12 years do not use 

  • Other information

    • each 30 mL contains: sodium 23 mg
    • store at 20-25ºC (68-77ºF)
    • do not refrigerate
    • protect from light
  • Inactive ingredients

    citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, citrate dihydrate

  • Questions or comments?

    Call 1-888-723-3929 Monday-Friday 7AM-6PM PST 

  • Principal Display Panel

    COMPARE TO ZZZQUIL® active ingredient*

    Nighttime Sleep Aid

    Diphenhydramine HCI 50 mg

    • Non-Habit Forming
    • Not for treating cold or flu
    • 10 % alcohol
    • See warnings

    Berry Flavor

    fl oz (mL)

    Failure to follow these warnings could results in serious consequenses.

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

    *This product is not manufactured  or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Proctor & Gamble Company.

    DISTRIBUTED BY

    BETTER LIVING BRANDS LLC

    P.O. BOX 99, PLEASANTON, CA 94566-0009

    www.betterlivingbrandsLLC.com

  • Package Label

    Diphenhydramine HCl 50 mg

    SIGNATURE CARE Nighttime Sleep Aid Berry Flavor

  • INGREDIENTS AND APPEARANCE
    EZ NITE SLEEP 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-014
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-014-242 in 1 PACKAGE, COMBINATION06/30/2015
    1355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:21130-014-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2015
    3NDC:21130-014-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/30/2015
    Labeler - Safeway, Inc. (009137209)
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