Label: NIGHTTIME SLEEP AID liquid

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

Drug Label Information

Updated January 16, 2024

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  • Active ingredient(s)

    Diphenhydramine HCl 50mg

  • Purpose

    Nighttime sleep-aid

  • Use(s)

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

    Do not use

    • Do not use n for children under 12 years of age.
    • with any other product containing diphenhydramine, even one used on skin
    • with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products

    Ask a doctor before use if

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

    Ask a doctor or pharmacist before use if

    you are taking sedatives or tranquilizers or any other sleep aid

    When using this product

    • do not use more than directed
    •  avoid alcoholic beverages and other drugs that cause drowsiness
    •  drowsiness will occur
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness

    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 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 right away.

  • Directions

    • take only as recommended
    • use dosage cup or tablespoon

    Age                                   Dose
    Adults & children

    12 years & over: One Dose = 2 tablespoons (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 (2 tablespoons) contains: sodium 23 mg
    • dosage cup provided
    • store at room temperature
  • Inactive ingredients

    citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn syrup,
    poloxamer 407, propylene glycol, purified water, sodium benzoate, sodium
    citrate, sodium saccharin

  • Questions/Comments

    Call 1-888-952-0050 Monday through Friday 9AM to 5PM

  • Principal Display Panel

    Sleep Aid Liquid

    Sleep Aid Liquid

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    nighttime sleep aid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-446
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN (UNII: FST467XS7D)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-446-39354 mL in 1 BOTTLE; Type 0: Not a Combination Product01/16/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01001/16/2024
    Labeler - Allegiant Health (079501930)
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