Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Floriva

Product Details

NDC Product Code

52796-177

Route of Administration

ORAL

Effective Date

February 1, 2024

Ingredients

Vitamin D3Active

Code: 1C6V77QF41Class: ACTIBQuantity: 600 [iU] in 1 1

Vitamin A acetateActive

Code: 3LE3D9D6OYClass: ACTIMQuantity: 1000 [iU] in 1 1

Beta caroteneActive

Code: 01YAE03M7JClass: ACTIBQuantity: 1000 [iU] in 1 1

RiboflavinActive

Code: TLM2976OFRClass: ACTIBQuantity: 1.5 mg in 1 1

NicotinamideActive

Code: 25X51I8RD4Class: ACTIBQuantity: 15 mg in 1 1

PyridoxineActive

Code: KV2JZ1BI6ZClass: ACTIBQuantity: 1.8 mg in 1 1

Vitamin CActive

Code: PQ6CK8PD0RClass: ACTIBQuantity: 75 mg in 1 1

ThiamineActive

Code: X66NSO3N35Class: ACTIBQuantity: 1.3 mg in 1 1

Folic acidActive

Code: 935E97BOY8Class: ACTIBQuantity: 100 ug in 1 1

Vitamin B12Active

Code: P6YC3EG204Class: ACTIBQuantity: 6 ug in 1 1

BiotinActive

Code: 6SO6U10H04Class: ACTIBQuantity: 40 ug in 1 1

Zinc gluconateActive

Code: U6WSN5SQ1ZClass: ACTIBQuantity: 5 mg in 1 1

Cupric oxideActive

Code: V1XJQ704R4Class: ACTIMQuantity: 1 mg in 1 1

Sodium fluorideActive

Code: 8ZYQ1474W7Class: ACTIMQuantity: 1 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

XYLITOLInactive

Code: VCQ006KQ1EClass: IACT

levomefolate calciumActive

Code: Q65PL71Q1AClass: ACTIBQuantity: 162 ug in 1 1

TocopherolActive

Code: H4N855PNZ1Class: ACTIBQuantity: 20 [iU] in 1 1

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

DESCRIPTION SECTION

Description

Off-white to pale yellow, speckled, berry flavored, hexagon shaped chewable tablet. Debossed "177" on one side and scored on the other.

DOSAGE & ADMINISTRATION SECTION

Directions

USE AS DIRECTED BY YOUR PHYSICIAN.

WARNINGS SECTION

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.

PRECAUTIONS SECTION

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.

STORAGE AND HANDLING SECTION

OTHER INFORMATION

You may report serious side effects to 1-844-640-7607. Store in a cool, dry place at room temperature 20-25º Celsius (68-77º 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.

SPL UNCLASSIFIED SECTION

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

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

LOT/EXP

Quatrefolic Trademark and Patent property of Gnosis SpA.

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Floriva

FDA Approval Summary

Products1

Floriva

Product Details

Drug Labeling Information

DESCRIPTION SECTION

Description

DOSAGE & ADMINISTRATION SECTION

Directions

WARNINGS SECTION

WARNING

PRECAUTIONS SECTION

CAUTION

STORAGE AND HANDLING SECTION

OTHER INFORMATION

SPL UNCLASSIFIED SECTION