Label: JANGDAEWON NATURE KIDS- lactobacillus rhamnosus powder

  • 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 March 13, 2019

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

  • ACTIVE INGREDIENT

    Active ingredients: Lactobacillus rhamnosus 1.3%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Organic Agave Inulin powder, Organic Alpha-rice flour, Organic Refined Glucose, Organic Tapioca Maltose Dextrin, Lactobacillus powder mix, Bacillus coagulans, Lactobacillus helveticus,

  • PURPOSE

    Purpose: Gut health

  • WARNINGS

    Warnings
    ■ Idiosyncratic or allergic person need to decide to take this product after consulting a doctor
    ■ In case of abnormal symptom, stop taking this product and consult a medical doctor or inquire to customer service.
    ■ Make sure to check expiry date, and please follow suggested use instruction.
    ■ Avoid direct ray of light and keep in cool and dry place, and keep out of the child's reach.
    ■ Consume this product as soon as opening, owing to the possibility of moisture absorption.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the child's reach.

  • Uses

    Uses:
    ■ May help increasing lactobacillus and reducing pathogenic bacteria
    ■ May help smooth bowel movement

  • Directions

    Directions:
    ■ Take 1 stick one dose daily with water or without water.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of box

  • INGREDIENTS AND APPEARANCE
    JANGDAEWON NATURE KIDS 
    lactobacillus rhamnosus powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72460-400
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lactobacillus rhamnosus (UNII: 9601IVB87J) (LACTOBACILLUS RHAMNOSUS - UNII:9601IVB87J) Lactobacillus rhamnosus26 mg  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    Bacillus coagulans (UNII: ISK1LOY57E)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72460-400-0230 in 1 BOX02/01/2019
    1NDC:72460-400-012 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2019
    Labeler - Daewon Pharmaceutical Co., Ltd. (689275501)
    Registrant - Daewon Pharmaceutical Co., Ltd. (689275501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Daewon Pharmaceutical Co., Ltd.689275501manufacture(72460-400)