Label: NIGHTTIME SLEEP AID BERRY FLAVOR- diphenhydramine hydrochloride liquid

  • NDC Code(s): 68163-730-06
  • Packager: Raritan Pharmaceuticals Inc
  • 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 September 2, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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

    ▪
    for children under 12 years of age
    ▪
    with any other product containing diphenhydramine, even one used on skin

    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

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

    When using this product

    ▪
    avoid alcoholic beverages

    Stop use and ask a doctor if sleeplessness 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:

    In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • Directions

    ▪
    take only one dose per day (24 hours)
    ▪
    only use cup provided

    adults & children 12yrs & over

    One Dose 30 mL at bed time if needed or as directed by a doctor

    Children under 12 yrs

    do not use
  • Other information

    ▪
    each 30 mL dose contains: potassium 5 mg, sodium 10 mg
    ▪
    store at room temperature
  • Inactive ingredients

    anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

  • PRINCIPAL DISPLAY PANEL

    DRx CHOICE®

    NDC 68163-730-06

    Compare to in ZzzQuil® Nighttime Sleep-Aid active ingredient *

    Sleep-Aid

    Nighttime

    Diphenhydramine HCl

    Non-Habit Forming

    BERRY FLAVOR

    Naturally and Artificially Flavored

    Not for treating Cold or Flu See Warnings

    6 FL OZ (177 mL)

    $1.99 AMAZING NEW VALUE!

    TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

    *This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

    Manufactured by:

    Raritan Pharmaceuticals

    8 Joanna Court,

    East Brunswick, NJ 08816

    DRx Choice Sleep Aid Nighttime Berry Flavor
  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID  BERRY FLAVOR
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-730
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorBERRY (Naturally and Artificially) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-730-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/17/2019
    Labeler - Raritan Pharmaceuticals Inc (127602287)
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