Description
Vitavera™ is a chewable multivitamin dietary supplement containing essential vitamins including Vitamins A, C, D, E, B-complex vitamins, and folate. It is formulated to support general nutritional supplementation and overall health.
Vitavera Tablet, Chewable
FDA Label NDC 85477-513
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oncora Pharma, Llc for the product Vitavera (NDC 85477-513). 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 description, indications and usage, warnings, precautions, adverse reactions, overdosage, dosage and administration, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications And Usage
Vitavera™ is indicated to provide supplemental amounts of essential vitamins including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate. It is intended to supplement the diet and help prevent nutritional deficiencies.
Formulated for use in patients requiring vitamin supplementation as directed by a licensed healthcare practitioner.
Warnings
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age.
Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Precautions
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.
The patient’s medical condition and concurrent use of medications, herbs, or supplements should be considered prior to use.
If pregnant, lactating, or trying to conceive, consult a licensed healthcare professional prior to use.
Adverse Reactions
Allergic sensitization has been reported following oral administration of folic acid.
Adverse reactions are generally rare at recommended dosages; however, hypersensitivity reactions may occur.
Overdosage
In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
Dosage And Administration
Usual adult dosage is one tablet daily, to be dissolved in the mouth or chewed before swallowing, or as directed by a licensed healthcare practitioner
How Supplied
Vitavera™ chewable multivitamin tablets are supplied as:
- 30 tablets per bottle
- NDC: 85477-513-30
- Round chewable tablets, cherry flavored
Dispense in a tight, light-resistant container as defined in the USP.
Principal Display Panel
Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature]
Protect from excessive heat, light, and moisture.
Vitavera™
Chewable Multivitamin
Cherry Flavor
30 Tablets
Rx Only
NDC 85477-513-30
Manufactured for:
Oncora Pharma
Dallas, TX 75228
Pdp (Vitavera 1)
* Please review the disclaimer below.
