Label: SLEEP GUMMIES chewable gel

  • NDC Code(s): 83739-004-01
  • Packager: XIAN CHIANG COMPANY LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 14, 2023

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

  • Active Ingredient

    Amino acids 2%, BARLEY MALT 1%

  • Purpose

    Promote sleep health Regulate the immune system

  • Uses

    Regulating immunity

  • Warnings

    For internal use only

  • Do not use

    If you are allergic to any ingredients

  • When Using Section

    When using this product , do not take other medications at the same timeIf taking antibiotics at the same time , please interval at least 2 hours ofollow medical advice

    If discomfort occurs after consumption , please stop using and consult a doctor

  • Stop Use Section

    No side effects

  • Keep out of reach of childre

    Children , pregnant women , and nursing mothers should not consume it

  • Instructions

    Once a day , 2 gummies each time , taken with warm water

    Seal and place in a cool and dry place

    This product cannot replace medication for treatment

  • Other information

    Other information store at 20-30°C ( 68-77F )

    protect from excessive

  • inactive ingredients

    Egg Shell Collagen , Phytoceramides , Reishi Fruiting Body Extract ,Magnesium Bisglycinate , L-Theanine , Liposomal Apigenin ( from chamomile ) , GABA , Vitamin C , Liposomal Hyaluronic Acid , Valarian Root, Blue Passion Flower Extract , Lemon Balm Leaf Extract , Vitamin B6, Chelated Zinc Oxide , Copper , Melatonin.

  • PRINCIPAL DISPLAY PANEL

    83739-004-01

  • INGREDIENTS AND APPEARANCE
    SLEEP GUMMIES 
    sleep gummies chewable gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83739-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BARLEY MALT (UNII: R3NBG8914U) (BARLEY MALT - UNII:R3NBG8914U) BARLEY MALT1 g  in 100 
    AMINO ACIDS (UNII: 0O72R8RF8A) (AMINO ACIDS - UNII:0O72R8RF8A) AMINO ACIDS2 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    VALERIAN (UNII: JWF5YAW3QW)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    REISHI (UNII: TKD8LH0X2Z)  
    MAGNESIUM GLYCINATE (UNII: IFN18A4Y6B)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    COPPER (UNII: 789U1901C5)  
    PENICILLOYL POLYLYSINE (UNII: RKH8WR95Z0)  
    THEANINE (UNII: 8021PR16QO)  
    PASSIFLORA CAERULEA FRUIT (UNII: 15H40G5NSR)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    PYRIDOXINE (UNII: KV2JZ1BI6Z)  
    APIGENIN (UNII: 7V515PI7F6)  
    .GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    MELATONIN (UNII: JL5DK93RCL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83739-004-0160 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/14/2023
    Labeler - XIAN CHIANG COMPANY LIMITED (662722809)
    Establishment
    NameAddressID/FEIBusiness Operations
    XIAN CHIANG COMPANY LIMITED662722809manufacture(83739-004)