Floriva™

Floriva™
SPL v4
SPL
SPL Set ID 54eeeeda-9314-4b7c-9efc-0bedfffb91b6
Route
ORAL
Published
Effective Date 2024-02-01
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cholecalciferol (400 [iU]) Fluoride Ion (0.25 mg)
Inactive Ingredients
Glycerin Water Polysorbate 80 Sodium Hydroxide Propylene Glycol Sucralose Methylparaben Propylparaben

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2014-10-15

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.


Medication Information

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.

Section 42229-5

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

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.

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.

Other Information

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

Principal Display Panel 50 Ml Bottle Label

52796-172-50

BonGeo

PHARMACEUTICALS

Floriva

0.25 mg DROPS

0.25 mg*

FLUORIDE

DROPS

Fluoride and Vitamin D

Liquid Drops

Fruit Flavor

Rx Dietary

Supplement

1 2/3 FL. OZ (50 mL)

SUGAR, SACCHARIN

AND GLUTEN FREE

NO ARTIFICIAL COLORS OR DYES

*contains 0.25 mg fluoride from 0.55 mg sodium fluoride


Structured Label Content

Description (34089-3)
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.

Section 42229-5 (42229-5)

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

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.

Warning (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.

Other Information (OTHER INFORMATION)

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

Principal Display Panel 50 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label)

52796-172-50

BonGeo

PHARMACEUTICALS

Floriva

0.25 mg DROPS

0.25 mg*

FLUORIDE

DROPS

Fluoride and Vitamin D

Liquid Drops

Fruit Flavor

Rx Dietary

Supplement

1 2/3 FL. OZ (50 mL)

SUGAR, SACCHARIN

AND GLUTEN FREE

NO ARTIFICIAL COLORS OR DYES

*contains 0.25 mg fluoride from 0.55 mg sodium fluoride


Advanced Ingredient Data


Raw Label Data

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