GOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]

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  • GOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]

GOOD SENSE SLEEP TIME (DIPHENHYDRAMINE HCL) SOLUTION [L. PERRIGO COMPANY]
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NDC 0113-0186-30, 0113-0186-40
Set ID 164200a9-b1f8-44c9-8598-a7dff5020e9d
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number PART338
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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 or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Non-Habit Forming

    SleepTime

    Nighttime Sleep-Aid

    Diphenhydramine HCl

    50 mg per 30 mL

    Berry Flavor

    Not For Treating Cold or Flu

    Compare to active ingredient of Vicks® ZzzQuil®

    100% SATISFACTION GUARANTEED

    6 FL OZ (177 mL)

    ALCOHOL 10%

    186-c2-sleeptime-1.jpg
    186-c2-sleeptime-2.jpg
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE SLEEP TIME 
    diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0186
    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 (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0186-30177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/02/2013
    2NDC:0113-0186-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product07/02/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33807/02/2013
    Labeler - L. Perrigo Company (006013346)
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