Florafol™ Pediatric (Multivitamin with 0.5 mg of Fluoride) Chewable Tablets

FloraFol by

Drug Labeling and Warnings

FloraFol by is a Prescription medication manufactured, distributed, or labeled by Pangea Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FLORAFOL- multivitamin and fluoride supplement tablet 
Pangea Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Florafol™ Pediatric (Multivitamin with 0.5 mg of Fluoride) Chewable Tablets

Florafol™

Pediatric (0.5 mg Fluoride) Multivitamin and Fluoride Chewable Tablet

Multivitamin and Fluoride Supplement

Florafol™ Pediatric (0.5 mg Fluoride) Multivitamin and Fluoride Chewable Tablet

Supplement Facts
Serving Size: 1 Tablet
Servings Per Cotainer: 30
		% Daily Values
Amount Per Serving		%DV Children 4-8 years	%DV Children; 9 years and older
Vitamin A (as Retinyl Acetate)	700 mcg	175%	117%
Vitamin B1 (as Thiamine Mononitrate)	1 mg	167%	111%
Vitamin B2 (as Riboflavin )	1 mg	167%	111%
Niacin (as Niacinamide)	12 mg	150%	100%
Vitamin B6 (as Pyridoxine HCl)	1.15 mg	192%	115%
Vitamin B12 (as Cyancobalamin)	3.5 mcg	292%	194%
Folate (as L-Methylfolate, Calcium Salt Metafolin)	250 mcg DFE	125%	83%
Vitamin C (as Sodium Ascorbate)	70 mg	280%	156%
Vitamin D (as Cholecalciferol)	12 mcg	80%	80%
Vitamin E (as D-Alpha-Tocopherol)	11.5 mg	164%	105%
Fluoride (as Sodium Fluoride)	0.5 mg	50%	25%

Other Ingredients: Xylitol, Sorbitol, Citric Acid Anhydrous, Monk Fruit Juice, Berry Flavor, Beet Root Juice, Carrageenan, Magnesium Stearate, Stearic Acid

Allergens: Fish Oil

Caution: This product should be chewed and is not recommended for children under age 4 due to risk of choking.

Distributed by:
Pangea Pharmaceuticals, LLC
Brielle, NJ 08730
1-855-892-8224
www.florafolrx.com

PRINCIPAL DISPLAY PANEL - Multivitamin with 0.5 mg of Fluoride

81279-102-30

FloraFol

(Multivitamin with 0.5 mg of Fluoride) Chewable Tablet MULTIVITAMIN & FLUORIDE SUPPLEMENT BERRY FLAVOR

0.5 mg

30 Tablets

FLORAFOL 
multivitamin and fluoride supplement tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 81279-102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	700 ug
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	12 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	1.15 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	3.5 ug
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLIC ACID	250 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	70 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	12 ng
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	11.5 mg
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 mg

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
SORBITOL (UNII: 506T60A25R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARRAGEENAN (UNII: 5C69YCD2YJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	11mm
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81279-102-30	1 in 1 PACKAGE	08/01/2024	05/13/2025
1		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2024	05/13/2025

Labeler - Pangea Pharmaceuticals, LLC (117751012)

Registrant - Pangea Pharmaceuticals, LLC (117751012)

Revised: 5/2025

Document Id: 353f6e3c-e80f-dad3-e063-6394a90a4480

34391-3

Set id: dcb3a043-9664-432b-ac98-f466828b9de2

Version: 4

Effective Time: 20250516