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

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.

Drug Label Information

Updated January 14, 2019

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  • 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

    label

  • INGREDIENTS AND APPEARANCE
    BIOVITA 
    bacillus subtilis, thiamine mononitrate, riboflavin, ascorbic acid, niacinamide, calcium phosphate, dibasic, dihydrate granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0032
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACILLUS SUBTILIS (UNII: 8CF93KW41W) (BACILLUS SUBTILIS - UNII:8CF93KW41W) BACILLUS SUBTILIS3 mg  in 1 g
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE20 mg  in 1 g
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE0.3 mg  in 1 g
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN0.2 mg  in 1 g
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID5 mg  in 1 g
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72689-0032-1120 g in 1 JAR; Type 0: Not a Combination Product12/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/25/2018
    Labeler - OASIS TRADING (689991468)
    Registrant - OASIS TRADING (689991468)
    Establishment
    NameAddressID/FEIBusiness Operations
    ILDONG PHARMACEUTICAL CO., LTD.689846555manufacture(72689-0032)
    Establishment
    NameAddressID/FEIBusiness Operations
    OASIS TRADING689991468label(72689-0032)