Floriva™

Floriva™
SPL v4
SPL
SPL Set ID 34b2924f-d220-4344-8cdd-e7dda54061c2
Route
ORAL
Published
Effective Date 2024-02-02
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Vitamin A (1000 [iU]) Beta Carotene (75 mg) Ascorbic Acid (600 [iU]) Cholecalciferol (20 [iU]) .alpha.-tocopherol (1.3 mg) Thiamine Ion (1.5 mg) Riboflavin (15 mg) Niacinamide (1.8 mg) Pyridoxine (162 ug) Levomefolate Glucosamine (100 ug) Folic Acid (6 ug) Cyanocobalamin (40 ug) Biotin (5 mg) Zinc Cation (1 mg) Cupric Cation (0.5 mg) Fluoride Ion
Inactive Ingredients
Microcrystalline Cellulose Sucralose Talc Magnesium Stearate Xylitol

Identifiers & Packaging

Pill Appearance
Imprint: 174 Shape: hexagon (6 sided) Color: white Size: 13 mm Score: 2
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2014-10-15

Description

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) 0.5 mg


Medication Information

Description

Off-white to pale yellow, speckled, berry flavored, hexagon shaped chewable tablet. Debossed "174" on one side and scored on the other.

Section 42229-5
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) 0.5 mg
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.

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.

Directions

USE AS DIRECTED BY YOUR PHYSICIAN.

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.

Other Ingredients

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

Tamper Evident Feature

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

Principal Display Panel 90 Tablet Bottle Label

0.5 mg*

FLUORIDE

TABLETS

BonGeo

PHARMACEUTICALS

52796-174-90

Floriva

0.5 mg TABLETS

Chewable Fluoride Multivitamin

Quatrefolic ®

Patent Ref.: U.S. Patent No. 7,947,662;

Other patents pending

Natural Berry Flavor

Rx Dietary Supplement

90 Chewable Tablets

*contains 0.5 mg fluoride

from 1.1 mg sodium fluoride

• SUGAR FREE AND GLUTEN FREE • NO ARTIFICIAL COLORS OR DYES •


Structured Label Content

Section 42229-5 (42229-5)
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) 0.5 mg
Caution (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.

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. TABLET SHOULD BE CHEWED. THIS TABLET, AS WITH ALL TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE OF 4 DUE TO RISK OF CHOKING.

Directions

USE AS DIRECTED BY YOUR PHYSICIAN.

Description

Off-white to pale yellow, speckled, berry flavored, hexagon shaped chewable tablet. Debossed "174" on one side and scored on the other.

Other Information (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.

Other Ingredients

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

Tamper Evident Feature

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

Principal Display Panel 90 Tablet Bottle Label (PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label)

0.5 mg*

FLUORIDE

TABLETS

BonGeo

PHARMACEUTICALS

52796-174-90

Floriva

0.5 mg TABLETS

Chewable Fluoride Multivitamin

Quatrefolic ®

Patent Ref.: U.S. Patent No. 7,947,662;

Other patents pending

Natural Berry Flavor

Rx Dietary Supplement

90 Chewable Tablets

*contains 0.5 mg fluoride

from 1.1 mg sodium fluoride

• SUGAR FREE AND GLUTEN FREE • NO ARTIFICIAL COLORS OR DYES •


Advanced Ingredient Data


Raw Label Data

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