69862-001_Deactivation

Drug Labeling and Warnings

Drug Details [pdf]

BIOVITA- bacillus subtilis, thiamine mononitrate, riboflavin, ascorbic acid, niacinamide, calcium phosphate, dibasic, dihydrate granule 
ILDONG 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.

----------

69862-001_Deactivation

Active ingredients (1g contains)
Bacillus subtilis 3.0 mg
Thiamine Nitrate 0.3 mg
Riboflavin 0.2 mg
Ascorbic Acid 5.0 mg
Nicotinamide 0.1 mg
Dibasic Calcium Phosphate Hydrate 20.0 mg

Digestion, Vitamins, and Calcium

Probiotic Digestion and Vitamin Supplement for babies.

Administer the following dose 4 times daily in water, milk or weaning baby food.
Infants: 1g / 1-2 years: 2g /3-4 years: 3g / 5-7 years: 4g
Infants: It is recommended to be taken BIOVITA which is dissolved in mild milk or water.
Bottle-fed infants: It is recommended to be taken BIOVITA and powdered milk which are mixed with mild water.

Do not administer this product to patients who are Galactose intolerance, Lapp lactase deficiency, or Glucose-glalactose malabsorption.

BIOVITA should be used carefully with patients under medical conditions.

Follow the dosage recommendations.

If symptoms do not improve after two weeks to one month, it is recommended to consult with physician or pharmacist.

Consult with a doctor or pharmacist for baby who is under 3 months that is administered with this product.

Keep in a dry and cool place without direct sunlight.

Keep out of reach of the children.

Lactose Hydrate, Lactobacillus sporogenes, Clostridium butyricum Miyairi, Sucrose, Citric Acid Hydrate, Vanillin, Dried Yeast

BIOVITA 
bacillus subtilis, thiamine mononitrate, riboflavin, ascorbic acid, niacinamide, calcium phosphate, dibasic, dihydrate granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69862-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACILLUS SUBTILIS (UNII: 8CF93KW41W) (BACILLUS SUBTILIS - UNII:8CF93KW41W)	BACILLUS SUBTILIS	3 mg  in 1 g
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J)	CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	20 mg  in 1 g
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	0.3 mg  in 1 g
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	0.2 mg  in 1 g
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	5 mg  in 1 g
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SUCROSE (UNII: C151H8M554)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
VANILLIN (UNII: CHI530446X)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
BACILLUS COAGULANS (UNII: ISK1LOY57E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69862-001-02	1 in 1 CARTON	06/03/2015	09/13/2019
1	NDC: 69862-001-01	120 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/03/2015	09/13/2019

Labeler - ILDONG PHARMACEUTICAL CO., LTD. (689846555)

Registrant - ILDONG PHARMACEUTICAL CO., LTD. (689846555)

Establishment
Name	Address	ID/FEI	Business Operations
Ildong Pharmaceutical Co., Ltd.		694860135	manufacture(69862-001)

Revised: 9/2019

Document Id: 92740aaf-8012-453c-e053-2995a90a42c2

34390-5

Set id: 1414abaf-1158-4d8b-8906-59dc85f17e1c

Version: 6

Effective Time: 20190913