Label: BIOVITA- bacillus subtilis, thiamine mononitrate, riboflavin, ascorbic acid, niacinamide, calcium phosphate, dibasic, dihydrate granule
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated January 14, 2019
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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.
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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
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)