VITAVERA tablet, chewable

Drug Labeling and Warnings

Drug Details [pdf]

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.

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.

General

Drug Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Nursing Mothers

Pediatric 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

INGREDIENTS AND APPEARANCE

VITAVERA 
vitavera tablet, chewable

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 85477-513
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	2500 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	30 mg
SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	30 mg
VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41)	VITAMIN D	400 [iU]
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL	15 [iU]
THIAMINE (UNII: X66NSO3N35) (Thiamine ION - UNII:4ABT0J945J)	THIAMINE	1 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)	NIACIN	13 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	1 mg
LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLIC ACID	1000 ug
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W)	METHYLCOBALAMIN	4 ug

Product Characteristics
Color	red	Score	no score
Shape	SEMI-CIRCLE	Size	18mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85477-513-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/07/2026

Labeler - Oncora Pharma, LLC (119482542)