Label: NIGHTTIME SLEEP AID liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 6, 2025

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  • Active ingredient(s)

    Diphenhydramine HCl 50 mg (in each 30 mL)

  • Purpose

    Nighttime sleep-aid

  • Use(s)

    • 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
    • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu product

    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

    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 2 weeks. Insomnia may be a symptom of a serious underlying medical
    illness.

    If pregnant or breastfeeding,

    ask a health professional before use.

    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

    • take only one dose (30 mL) per day (24 hours)
    • only use dose cup provided

     AgeDose
    adults & children 12 yrs & over30 mL at bedtime if needed or as directed by a doctor
    children under 12 yrsdo not use

  • Other information

    • each 30 mL dose cup contains: sodium 24 mg
    • store between 15-30°C (59-86°F).

    TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING

  • Inactive ingredients

    anhydrous citric acid, FD&C Blue #1, FD&C
    Red #40, flavor, glycerin, menthol, propylene glycol, purified water,
    sodium benzoate, sodium citrate, sorbitol, sucralose.

  • Questions/Comments

    Call 1-888-952-0050

    (Monday-Friday 9 AM – 5 PM EST)

  • Principal Display Panel

    Nighttime Sleep Aid

    Nighttime Sleep Aid

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    nighttime sleep aid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-486
    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)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-486-39355 mL in 1 BOTTLE; Type 0: Not a Combination Product08/06/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01008/06/2025
    Labeler - Allegiant Health (079501930)
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