Label: REXALL SLEEP AID- diphenhydramine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated December 6, 2019

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  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    for relief of occasional sleeplessness

  • 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.

  • 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
  • Other information

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

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

  • Principal Display Panel

    Sleep-Aid

    Non-habit forming

    For a restful night’s sleep

    Contains no pain reliever

    Nighttime Sleep-Aid

    Diphenhydramine Hydrochloride

    100 Rapid Release Caplets

    GLUTEN FREE

    Sleep-Aid image
  • INGREDIENTS AND APPEARANCE
    REXALL SLEEP AID 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-702
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code L151
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-702-781 in 1 CARTON09/29/2010
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33809/29/2010
    Labeler - Dolgencorp, LLC (068331990)
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