Floriva Tablet, Chewable
FDA Label NDC 52796-173

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bongeo Pharmaceuticals, Inc. for the product Floriva (NDC 52796-173). 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 other, other ingredients, description, directions, tamper evident feature, warning, caution, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Other Ingredients

→ Description

→ Directions

→ Tamper Evident Feature

→ Warning

→ Caution

→ Other Information

→ Principal Display Panel - 90 Tablet Bottle Label

Other

Supplement Facts
Serving Size: 1 tablet Servings Per Container: 90
	Amount per tablet	% Daily Value Percent Daily Value (%DV) for Adults and Children 4 or more years of age based on a 2000 calorie diet.
Vitamin A (50% beta carotene/50% acetate)	2000 IU	40%
Vitamin C (ascorbic acid)	75 mg	125%
Vitamin D3 (cholecalciferol)	600 IU	150%
Vitamin E (dl alpha tocopherol acetate)	20 IU	67%
Vitamin B1 (thiamine)	1.3 mg	87%
Vitamin B2 (riboflavin)	1.5 mg	88%
Niacin (nicotinamide)	15 mg	75%
Vitamin B6 (pyridoxine)	1.8 mg	90%
Folate (as 300 mcg Quatrefolic R ((6S-5-methyltetrahydrofolic acid, glucosamine salt Daily Value not established. , molar equivalent to 162 mcg of folic acid) and 100 mcg of folic acid) Quatrefolic CAS #: 1181972-37-1	262 mcg	66%
Vitamin B12 (cyanocobalamin)	6 mcg	100%
Biotin	40 mcg	13%
Zinc (zinc gluconate)	5 mg	33%
Copper (cupric oxide)	1 mg	50%
Fluoride (sodium fluoride)	0.25 mg

Manufactured for:
BonGeo Pharmaceuticals, Inc.
Roseland, NJ 07068

Manufactured by:
Sancilio & Co., Inc.
Riviera Beach, FL 33404

Other Ingredients

Natural berry flavor, bitterness masking agent, MCC, sucralose, talc, magnesium stearate, xylitol (DC and regular grade).

Description

Off-white to pale yellow, speckled, berry flavored, hexagon shaped chewable tablet. Debossed "173" on one side and scored on the other.

Quatrefolic Trademark and Patent property of Gnosis SpA.

Directions

USE AS DIRECTED BY YOUR PHYSICIAN.

Tamper Evident Feature

Do not use if inner-seal beneath cap is missing or broken.

Warning

KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222. TABLET SHOULD BE CHEWED. THIS TABLET, AS WITH ALL TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE OF 4 DUE TO RISK OF CHOKING.

Caution

Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.

Other Information

You may report serious side effects to 1-844-640-7607. Store in a cool, dry place at room temperature 20-25° Celsius (68-77° Fahrenheit) away from heat and sunlight. Store in original container.

The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health insurance and state level reimbursement programs and is not intended to denote registration with the FDA.

The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.