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

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.

----------

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

label

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:72689-0032
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72689-0032-1	120 g in 1 JAR; Type 0: Not a Combination Product	12/25/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		12/25/2018

Labeler - OASIS TRADING (689991468)

Registrant - OASIS TRADING (689991468)

Name	Address	ID/FEI	Business Operations
Establishment
ILDONG PHARMACEUTICAL CO., LTD.		689846555	manufacture(72689-0032)

Name	Address	ID/FEI	Business Operations
Establishment
OASIS TRADING		689991468	label(72689-0032)