Floriva Liquid
FDA Label NDC 52796-172

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 52796-172). 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, warning, directions, how to use, caution, other information, other, principal display panel - 50 ml bottle label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Description

→ Warning

→ Directions

→ How To Use

→ Caution

→ Other Information

→ Other

→ Principal Display Panel - 50 Ml Bottle Label

Description

Supplement Facts
Serving Size: 1 mL
Servings Per Container: 50
	Amount per serving	% Daily Value Percent Daily Value (%DV) based on a 2000 calorie diet.
Vitamin D	400 IU	100%
Fluoride (sodium fluoride)	0.25 mg	Daily Value not established.

Other Ingredients: Glycerin, water, polysorbate 80, sodium hydroxide, propylene glycol, sucralose, fruit flavor, methyl paraben, caramel color and propyl paraben.

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.

SHAKE WELL BEFORE USE

Directions

Use as directed by a physician

How To Use

Fill dropper to appropriate line and dispense with a single squeeze of the dropper bulb. The full dose will be given. It is normal for a small amount to remain in the tip of the dropper.

Do not accept if tamper evident box seal is broken or missing.

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

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) since these may decrease effectiveness. Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis.

Other Information

You may report serious side effects to 1-844-640-7607.

Other

The numeric identifer 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.

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

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

LOT/EXP