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

BIOVITA by

Drug Labeling and Warnings

BIOVITA by is a Otc medication manufactured, distributed, or labeled by OASIS TRADING, ILDONG PHARMACEUTICAL CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Digestion, Vitamins, and Calcium

INDICATIONS & USAGE

Probiotic Digestion and Vitamin Supplement for babies.

DOSAGE & ADMINISTRATION

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.

WARNINGS

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 CHILDREN

Keep out of reach of the children.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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: 72689-0032-1	120 g in 1 JAR; Type 0: Not a Combination Product	12/25/2018

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

Labeler - OASIS TRADING (689991468)

Registrant - OASIS TRADING (689991468)

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

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