Label: SLEEP AID- diphenhydramine hcl capsule, liquid filled

  • NDC Code(s): 50844-228-13, 50844-228-19, 50844-228-27
  • Packager: L.N.K. International, 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 October 21, 2021

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

  • Active ingredient (in each liquid-filled capsule)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • for relief of occasional sleeplessness
    • reduces time to fall asleep if you have difficulty falling asleep
  • Warnings

    Do not use

    • for 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
    • difficulty in urination due to enlargement of the prostate gland
    • glaucoma

    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 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

    • do not take more than directed
    • adults and children 12 years and over: take 1 capsule at bedtime if needed, or as directed by a doctor
    • children under 12 years: do not use
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • protect from light, heat and moisture
    • see end flap for expiration date and lot number
  • Inactive ingredients

    FD&C blue #1, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution, white ink

  • Questions or comments?

    ​1-800-426-9391

  • Principal display panel

    QUALITY
    + PLUS

    NDC 50844-228-19

    *Compare to active ingredient in
    Unisom® SleepGels®

    SLEEP AID
    Diphenhydramine HCl 50 mg
    NIGHTTIME SLEEP-AID

    Safe, Effective & Non-habit Forming
    Helps You Fall Asleep

    8
    Liquid Gels

    One Liquid Gel
    Per Dose

    ACTUAL SIZE

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT
    IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by
    Chattem, Inc., owner of the registered trademark
    Unisom® SleepGels®.     50844     ORG012072819

    Distributed by LNK INTERNATIONAL, INC.
    60 Arkay Drive
    Hauppauge, NY 11788
    USA
    Product of Dubai
    Packaged and Quality Assured in the USA

    Quality Plus 44-728

    Quality Plus 44-728

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-228
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code 728
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50844-228-191 in 1 CARTON11/19/2020
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50844-228-13250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2020
    3NDC:50844-228-274 in 1 CARTON11/19/2020
    38 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33811/19/2020
    Labeler - L.N.K. International, Inc. (038154464)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(50844-228)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(50844-228)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(50844-228)