Label: DIPHENHYDRAMINE HYDROCHLORIDE 50MG capsule, liquid filled

  • 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 January 12, 2022

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  • ACTIVE INGREDIENT

    Diphenhydramine HCl 50mg

    Dipheyhydramine HCl 50mg

  • Use

    For relief of occasional sleeplessness

    for relied of occasional sleeplessness

  • Warnings

    for children under 12 years of age

    with any other products containing diphenhydramine, even one used on skin

    Ask a doctor or pharmacist before use if

    you have a breathing problem such as emphysema or chronic bronchitis, glaucoma, trouble urinating due to an enlarged prostate gland

    you are taking sedatives or tranquilizers

    When using this product

    avoid alcholic drinks

    Stop use and ask a doctor if

    sleeplessness presists continuously for more than 2 weeks. Insomnic may be a symptom of a series underlying medical illness

    If pregnant or breast-feeding

    ask a health professional before use

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

  • Direction

    adults and children 12 years and over: 1 softgel at bedtime if needed, or as directed by a doctor

  • INACTIVE INGREDIENT

    FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

  • PRINCIPAL DISPLAY PANEL

    RxZell

    SleepAid

    Dyphenhydramine HCl 50mg

    Non Habit-Forming

    Easy to Swallow

  • Package.Label Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 50MG 
    diphenhydramine hydrochloride 50mg capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73629-001
    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
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorblue (clear) Scoreno score
    ShapeOVALSize13mm
    FlavorImprint Code PC13
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73629-001-22220 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33809/21/2020
    Labeler - AMZ789 LLC (117410213)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutra-Med Packaging Inc.022004902pack(73629-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287manufacture(73629-001) , analysis(73629-001)
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