Label: SLEEPINAL- diphenhydramine hydrochloride capsule

  • NDC Code(s): 50486-616-16, 50486-616-32
  • Packager: Blairex Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 23, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each capsule)

    Diphenhydramine hydrochloride 50 mg

  • Purpose

    night-time 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
    • glaucoma
    • trouble urinating due to the enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives

    When using this product avoid alcoholic drinks.

    Stop use and ask doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 1 capsule at bedtime if needed, or as directed by a doctor.
  • Other information

    • store at 15-30°C (59-86°F)
    • protect from excessive moisture
    • protect from light
    • retain product in box until administered
  • Inactive ingredients

    FD&C blue no. 1, FD&C red no. 3, gelatin, lactose, magnesium stearate, talc

    Manufactured for:

    Blairex Laboratories, Inc.
    P.O. Box 2127 Columbus, IN 47202 USA

  • QUESTIONS

    Telephone Questions or Comments? Call TOLL FREE 1-800-252-4739
    www.sleepinal.net

  • PRINCIPAL DISPLAY PANEL

    MAXIMUM STRENGTH

    Sleepinal ®

    Night-time Sleep-Aid CAPSULES

    NDC 50486-616-32

    Non-habit Forming

    One Capsule Dosage

    Wake Up Refreshed

    32 Capsules

    Diphenhydramine Hydrochloride

    PACKAGE NOT CHILD RESISTANT

    Principal Display Panel
  • PRINCIPAL DISPLAY PANEL

    MAXIMUM STRENGTH

    Sleepinal ®

    Night-time Sleep-Aid CAPSULES

    NDC 50486-616-16

    Non-habit Forming

    One Capsule Dosage

    Wake Up Refreshed

    16 Capsules

    Diphenhydramine Hydrochloride

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    SLEEPINAL 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50486-616
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    Product Characteristics
    Colorblue (transparent) Scoreno score
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code SLEEPINAL;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50486-616-324 in 1 CARTON10/01/1999
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50486-616-162 in 1 CARTON10/01/1999
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33810/01/1999
    Labeler - Blairex Laboratories, Inc. (092575133)
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