Label: AXIV - VROZZZ- diphenhydramine hydrochloride capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 25, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Diphenhydramine HCl

    Active Ingredient (in each softgel)Purpose
    Diphenhydramine HCl 25 mgNighttime Sleep-Aid

  • Uses

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

    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, consult your doctor. 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

    Keep out of reach of children.

    Overdose warning

    Do not take more than recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • take only 2 softgels per day (24 hours)
    adults & children 12 years and overtake 2 softgels at bedtime if needed, or as directed by a doctor
    children under 12 yearsdo not use

  • Other information

    • store between 20-25°C (68-77 °F)
    • tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.
  • Inactive ingredients

    FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide.

  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark VICKS® ZzzQuil® Nighttime Sleep-Aid LiquidCaps™.

    Lic. No.: "DD/DRUGS/DD/416"

    Distributed by: Vivunt Pharma LLC

    8590 w 74TH Court, Suite 1901

    Miami, FL 33156-3178

    Made in India

    www.vivunt.live

  • PRINCIPAL DISPLAY PANEL

    Compare to VICKS® ZzzQuil®

    Nighttime Sleep-Aid LiquidCaps™ active ingredient*

    NDC 82706-014-01

    AXIV - VroZzz

    Sleep Aid

    For Nighttime Use

    Fast Acting

    Non-Habit Forming

    Diphenhydramine HCl

    72 Softgels** **Liquid-filled capsules

    Vrozzz1

  • INGREDIENTS AND APPEARANCE
    AXIV - VROZZZ 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-014
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code AXIV
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82706-014-016 in 1 CARTON03/07/2024
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01003/07/2024
    Labeler - Vivunt Pharma LLC (045829437)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTECH PHARMA PRIVATE LIMITED677111277manufacture(82706-014)
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