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

(Multivitamin with 1.0 mg of Fluoride) Chewable Tablet

Multivitamin and Fluoride Supplement

Multivitamin and Fluoride Supplement

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 mcg175%117%
Vitamin B1 (as Thiamine Mononitrate)1 mg167%111%
Vitamin B2 (as Riboflavin )1 mg167%111%
Niacin (as Niacinamide)12 mg150%100%
Vitamin B6 (as Pyridoxine HCl)1 mg192%115%
Vitamin B12 (as Cyancobalamin)3.5 mcg292%194%
Folate (as L-Methylfolate, Calcium Salt Metafolin)250 mcg DFE125%83%
Vitamin C (as Sodium Ascorbate)70 mg280%156%
Vitamin D (as Cholecalciferol) 12 mcg80%80%
Vitamin E (as D-Alpha-Tocopherol) 11.5 mg164%105%
Fluoride (as Sodium Fluoride)1.0 mg100%50%

Other Ingredients: Xylitol, Sorbitol, Citric Acid Anhydrous, Stevia/Monk Fruit, 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 1.0 mg of Fluoride

81279-103-30

FloraFol

(Multivitamin with 1.0 mg of Fluoride) Chewable Tablet MULTIVITAMIN & FLUORIDE SUPPLEMENT BERRY FLAVOR

1.0 mg

30 Tablets

103-30

FLORAFOL 
multivitamin and fluoride supplement tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:81279-103
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A700 ug
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE12 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE1.15 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN3.5 ug
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID250 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID70 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL12 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 ION1 mg
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
SORBITOL (UNII: 506T60A25R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize11mm
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81279-103-301 in 1 PACKAGE06/13/2024
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/10/2024
Labeler - Pangea Pharmaceuticals, LLC (117751012)
Registrant - Pangea Pharmaceuticals, LLC (117751012)

Revised: 6/2024
Document Id: 71f5e3a2-c5f0-47c9-a51b-36faa9b29443
Set id: 19a83eca-36af-471c-a7dd-d84d7f72eb1c
Version: 2
Effective Time: 20240619
 
Pangea Pharmaceuticals, LLC