Label: GOOD NEIGHBOR PHARMACY SLEEP TIME- diphenhydramine hydrochloride solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/14

If you are a consumer or patient please visit this version.

  • Active ingredient (in each 30 mL dose cup)

    Diphenhydramine HCl 50 mg

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  • Purpose

    Nighttime sleep-aid

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  • Uses

    for the relief of occasional sleeplessness
    reduces time to fall asleep if you have difficulty falling asleep
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  • 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 products
    with other Nighttime products

    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
    drowsiness will occur
    do not drive a motor vehicle or operate machinery

    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.

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  • Keep out of reach of children.

    Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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  • Directions

    take only one dose per day (24 hours) – see Overdose warning
    use dose cup
     
    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 dose cup contains: sodium 20 mg
    store at 20-25˚C (68-77˚F)
    protect from light. Does not meet USP <671>.
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  • 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

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  • Questions or comments?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    Compare to Vicks® ZzzQuil® active ingredient

    NON-HABIT FORMING

    Sleep Time

    Diphenhydramine HCl

    50 mg per 30 mL

    Nighttime Sleep-Aid

    Not for treating Cold or Flu

    See Warnings

    10% ALCOHOL

    Berry Flavor

    6 fl oz (177 mL)

    Good Neighbor Pharmacy Sleep Time
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  • INGREDIENTS AND APPEARANCE
    GOOD NEIGHBOR PHARMACY SLEEP TIME 
    diphenhydramine hcl solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:46122-204
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    ANHYDROUS CITRIC ACID  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    HIGH FRUCTOSE CORN SYRUP  
    POLOXAMER 407  
    PROPYLENE GLYCOL  
    WATER  
    SACCHARIN SODIUM  
    SODIUM BENZOATE  
    SODIUM CITRATE  
    Product Characteristics
    Color PURPLE Score     
    Shape Size
    Flavor BERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46122-204-30 177 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part338 07/22/2013
    Labeler - Amerisource Bergen (007914906)
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