Label: REXALL SLEEP AID- diphenhydramine hydrochloride tablet 

  • 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 10/11

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

  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

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  • Purpose

    Nighttime sleep-aid

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  • Uses

    for relief of occasional sleeplessness

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  • Warnings

    Do not use

    • in 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
    • trouble urinating due to an enlarged prostate gland
    • glaucoma

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    avoid alcoholic drinks

    Stop use and ask a doctor if

    sleeplessness lasts 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.

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  • Directions

    adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by a doctor
    children under 12 years do not use
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  • Other information

    • store at 20º-25ºC (68º-77ºF)
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  • Inactive ingredients

    crospovidone, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

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  • Principal Display Panel

    Sleep-Aid

    Non habit-forming

    For a restful night’s sleep

    Contains no pain reliever

    Nighttime Sleep-Aid

    Diphenhydramine Hydrochloride

    GLUTEN FREE

    Rapid Release

    Sleep-Aid Carton Image 1

    Sleep-Aid Carton Image 1

    Sleep-Aid Carton Image 2

    Sleep-Aid Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    REXALL SLEEP AID 
    diphenhydramine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55910-702
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSPOVIDONE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYVINYL ALCOHOL  
    POVIDONE  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    POLYETHYLENE GLYCOLS  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 16mm
    Flavor Imprint Code L151
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55910-702-78 1 in 1 CARTON
    1 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part338 09/29/2010
    Labeler - Dolgencorp, LLC (068331990)
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