JANGDAEWON PROBIOTICS- lactobacillus rhamnosus powder

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Lactobacillus rhamnosus (UNII: 9601IVB87J) (LACTOBACILLUS RHAMNOSUS - UNII:9601IVB87J)
Available from:
Daewon Pharmaceutical Co., Ltd.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Gut health Uses: ■ May help increasing lactobacillus and reducing pathogenic bacteria ■ May help smooth bowel movement
Authorization status:
unapproved drug other
Authorization number:
72460-600-01, 72460-600-02

JANGDAEWON PROBIOTICS- lactobacillus rhamnosus powder

Daewon Pharmaceutical Co., Ltd.

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.

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ACTIVE INGREDIENT

Active ingredients: Lactobacillus rhamnosus 1.5%

INACTIVE INGREDIENT

Inactive ingredients:

Organic Refined Glucose, Organic Agave Inulin powder, Organic Alpha-rice flour, Organic Tapioca

Maltose Dextrin, Lactobacillus powder mix, Corn, Bifidobacterium longum, Bifidobacterium infantis,

Enterococcus faecium, Zinc oxide, Vitamin B6, Vitamin B1, Vitamin B2

PURPOSE

Purpose: Gut health

WARNINGS

Warnings

■ Pregnant of lactating women or who takes other medicines need to consult a professional before

taking this product.

■ 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.

Us es

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

JANGDAEWON PROBIOTICS

lactobacillus rhamnosus powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7246 0 -6 0 0

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

La cto ba cillus rha mno sus (UNII: 9 6 0 1IVB8 7J) (LACTOBACILLUS RHAMNOSUS -

UNII:9 6 0 1IVB8 7J)

La c to ba c illus

rha mno sus

30 mg

in 2 g

Inactive Ingredients

Ingredient Name

Stre ng th

Bifido ba cterium lo ng um (UNII: 8 31AQW6 9 9 W)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Daewon Pharmaceutical Co., Ltd.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7246 0 -6 0 0 -0 2

30 in 1 BOX

0 2/0 1/20 19

1

NDC:7246 0 -6 0 0 -0 1

2 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 2/0 1/20 19

Labeler -

Daewon Pharmaceutical Co., Ltd. (689275501)

Registrant -

Daewon Pharmaceutical Co., Ltd. (689275501)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Daewo n Pharmaceutical Co ., Ltd.

6 8 9 27550 1

ma nufa c ture (7246 0 -6 0 0 )

Revised: 3/2019

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