The following Structured Product Label (SPL) was submitted to the FDA by Oasis Trading for the product Biovita (NDC 72689-0032). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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 (Label)
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