BIOVITA

Manufacturer
OASIS TRADING | ILDONG PHARMACEUTICAL CO., LTD.
Effective date
2019-01-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:13

Label at a glance#

ProductBIOVITA
Active ingredientBACILLUS SUBTILIS, CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE, THIAMINE MONONITRATE, RIBOFLAVIN, ASCORBIC ACID, NIACINAMIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Digestion, Vitamins, and Calcium

INDICATIONS & USAGE SECTION

Probiotic Digestion and Vitamin Supplement for babies.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children.

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72689-0032-1BIOVITA120 g in 1 JARGRANULE1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72689-0032BIOVITA (BACILLUS SUBTILIS, THIAMINE MONONITRATE, RIBOFLAVIN, ASCORBIC ACID, NIACINAMIDE, CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE) GRANULE [OASIS TRADING]1Legacy NDC, 1 package rows20190117_7f6517b2-e33e-ab24-e053-2991aa0a3804.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72689-003272689-0032-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7f6517b2-e33f-ab24-e053-2991aa0a38047f6517b2-e33e-ab24-e053-2991aa0a38042019-01-14WarningsExact identifier
spl id: 7f6517b2-e33f-ab24-e053-2991aa0a3804
spl set id: 7f6517b2-e33e-ab24-e053-2991aa0a3804

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.