Label: EQUALINE NIGHT TIME SLEEP AID- diphenhydramine hydrochloride liquid 

  • Label RSS
  • NDC Code(s): 41163-186-30, 41163-186-40
  • Packager: Supervalu Inc
  • 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 09/13

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

    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
     
    One dose = 30 mL at bed time if needed or as directed by a doctor

    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?

    1-877-932-7948

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  • Package/Label Principal Display Panel

    compare to Vicks® ZzzQuil® Nighttime Sleep-Aid active ingredient

    night time sleep-aid

    diphenhydramine HCl 50 mg per 30 mL

    non-habit forming

    not for treating cold or flu

    see warnings

    ALCOHOL 10%

    berry flavor

    12 FL OZ (355 mL)

    SuperValu Night Time Sleep-Aid Image 1
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  • INGREDIENTS AND APPEARANCE
    EQUALINE NIGHT TIME SLEEP AID 
    diphenhydramine hcl liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41163-186
    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:41163-186-30 1 in 1 CARTON
    1 177 mL in 1 BOTTLE
    2 NDC:41163-186-40 1 in 1 CARTON
    2 355 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part338 06/28/2013
    Labeler - Supervalu Inc (006961411)
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