BIOVITA: Package Insert and Label Information

BIOVITA- bacillus subtilis, calcium phosphate, dibasic, dihydrate, thiamine mononitrate, riboflavin, ascorbic acid and niacinamide 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
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACILLUS SUBTILIS (BACILLUS SUBTILIS) BACILLUS SUBTILIS 3 mg in 1 g
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (ANHYDROUS DIBASIC CALCIUM PHOSPHATE) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 20 mg in 1 g
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 0.3 mg in 1 g
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 0.2 mg in 1 g
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 5 mg in 1 g
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 0.1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
SUCROSE
CITRIC ACID MONOHYDRATE
VANILLIN
YEAST, UNSPECIFIED
BACILLUS COAGULANS
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72689-0032-1 120 g in 1 JAR None
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 Operations
ILDONG PHARMACEUTICAL CO., LTD. 689846555 manufacture (72689-0032)
Establishment
Name Address ID/FEI Operations
OASIS TRADING 689991468 label (72689-0032)

Revised: 01/2019 OASIS TRADING

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