Label: NITETIME SLEEP AID- diphenhydramine hcl solution

  • NDC Code(s): 41250-044-30, 41250-044-40, 41250-044-50
  • Packager: Meijer Distribution Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 17, 2024

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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

    ▪
    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 an 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 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.

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

  • Directions

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

    adults & children 12 yrs & over

    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 contains: sodium 20 mg
    •
    store at 20-25˚C (68-77˚F)
  • Inactive ingredients

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

  • Questions?

    1-800-719-9260

  • Package/Label Principal Display Panel

    meijer®

    NON-HABIT FORMING

    Nighttime Sleep-Aid

    Diphenhydramine HCl 50 mg per 30 mL

    COMPARE TO VICKS® ZZZQUIL® ACTIVE INGREDIENTS

    HELPS YOU FALL ASLEEP

    BERRY FLAVOR

    ALCOHOL 10%

    Not for treating colds or flu

    12 FL OZ (355 mL)

    nighttime sleep-aid
  • INGREDIENTS AND APPEARANCE
    NITETIME SLEEP AID 
    diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-044
    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
    ALCOHOL (UNII: 3K9958V90M)  
    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)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-044-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product12/04/2014
    2NDC:41250-044-30177 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/201512/31/2021
    3NDC:41250-044-502 in 1 CARTON05/17/201805/31/2024
    3355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01012/04/2014
    Labeler - Meijer Distribution Inc (006959555)
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