FLORAFOL PEDIATRIC 0.25 MG/ML MULTIVITAMIN AND FLUORIDE LIQUID DROPS- vitamin a (as retinyl palmitate) vitamin c (as ascorbic acid) vitamin d3 (as cholecalciferol) vitamin e (as d-alpha-tocopherol acetate) vitamin b1 (as thiamine hcl) vitamin b2 (as riboflavin phosphate sodium) niacin (as niacinamide) vitamin b6 (pyridoxine hcl) folate (as 69 mcg quatrefolic ((6s)-5 methyltetrahydrofolate, glucosamine salt, molar equivalent to 37.5 mcg of folic acid)) vitamin b12 (as cyanocobalamin) fluoride (as sodium fluoride) solution/ drops 
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 0.25 mg/mL Multivitamin and Fluoride Liquid Drops

Supplement Facts
Serving Size : 1mL
Servings per container: 50

% Daily Value

Amount per serving 1mL

Infants 7-12 months

Children
1-3 yrs

Children
4-8 yrs

VITAMIN A (as Retinyl Palmitate)

450 mcg

90%

150%

113%

VITAMIN C (as Ascorbic Acid)

36 mg

72%

240%

144%

VITAMIN D3 (as Cholecalciferol)

10 mcg

100%

67%

67%

VITAMIN E (as d-Alpha-Tocopherol Acetate)

3.35 mg

45%

38%

32%

VITAMIN B1 (as Thiamine HCl) 

0.5 mg

167%

100%

83%

VITAMIN B2 (as Riboflavin Phosphate Sodium)

0.6 mg

150%

120%

100%

NIACIN (as Niacinamide)

4 mg

100%

67%

50%

VITAMIN B6 (Pyridoxine HCl)

0.4 mg

133%

80%

67%

Folate (as 69 mcg Quatrefolic® 
((6S)-5 Methyltetrahydrofolate, glucosamine salt, molar equivalent to 37.5 mcg of Folic Acid))

117 mcg DFE

147%

78%

59%

VITAMIN B12 (as Cyanocobalamin)

2 mcg

400%

222%

167%

FLUORIDE (as Sodium Fluoride) 

0.25 mg

50%

36%

25%

Other Ingredients: Purified Water, Glycerin, Sorbitol, Sucralose, Sodium Benzoate, Potassium Sorbate, Sodium Carbonate, Monoammonium glycyrrhizinate, Grape Flavor.

INDICATIONS & USAGE

Florafol™ Pediatric 0.25 mg/mL Fluoride, is a multivitamin and fluoride prescription product providing essential vitamins, minerals and fluoride.

CONTRAINDICATIONS

Do not use in areas where drinking water exceeds 0.6 ppm Fluoride. Do not administer to pediatric patients less than 6 months old.

PRECAUTIONS

General

Do not use this product if you are allergic to any of the ingredients. The suggested dose should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride. Do not eat or drink dairy products within one hour of fluoride administration since these may decrease effectiveness.

Folic Acid

Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Other Information

Call your doctor for medical advice about side effects. You may report serious side effects by calling Pangea Pharmaceuticals, LLC, at 1-855-892-8224.

WARNINGS

Keep out of the reach of children. In case of accidental overdose, seek professional emergency assistance or contact a Poison Control Center immediately.

DOSAGE AND ADMINISTRATION

See schedule below to determine dosage. Administer orally as prescribed by a healthcare practitioner. Use with calibrated dropper for measuring doses.

Fluoride Ion Level In Drinking Water (ppm)* 

Age

  Less than 0.3ppm 

 0.3-0.6 ppm

  Greater than 0.6 ppm

Birth-6 months

6 months-3 years

3-6 years

  None

  0.25 mg/day†

  0.50 mg/day†

 None

 None

 0.25 mg/day

  None

  None

  None

6-16 years

  1.0 mg/day

 0.50 mg/day

  None 

* 1.0 part per million (ppm) = 1 milligram/liter (mg/L)

† 2.2 mg sodium fluoride contains 1 mg fluoride ion

Dietary Fluoride Supplement dosing schedule approved by the American Dental Association (ADA), American Academy of Pediatrics (AAP) & American Academy of Pediatric Dentistry (AAPD).

DESCRIPTION

Florafol™ Pediatric 0.25 mg/mL Fluoride, multivitamin and fluoride liquid drops is a dye free and gluten free grape flavored product.

HOW SUPPLIED

Florafol™ Pediatric 0.25 mg/mL Fluoride is supplied in 50 mL (1-2/3 fl. oz.) child-resistant bottles with accompanying calibrated dropper (Product Code: 81279-100-50).

Rx Only

STORAGE

Store in a cool, dry place at room temperature 68 °F to 77 °F (20 °C to 25 °C) away from direct heat and sunlight.
Do not refrigerate this product.

SHAKE WELL BEFORE USE

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.

TAMPER EVIDENT

Do not use if seal is broken or missing.

Quatrefolic® is a registered trademark of Gnosis, SpA.


Manufactured for:
Pangea Pharmaceuticals, LLC,
Brielle, NJ 08730

Rev 12/2023

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

label

carton

81279-100-50
Florafol ™
PEDIATRIC
Multivitamin & Fluoride Liquid Drops
0.25 mg/mL Fluoride
Dye Free • Gluten Free
Rx Only • Grape Flavor
50 mL
(1⅔ fl oz.)

FLORAFOL PEDIATRIC 0.25 MG/ML MULTIVITAMIN AND FLUORIDE LIQUID DROPS 
vitamin a (as retinyl palmitate) vitamin c (as ascorbic acid) vitamin d3 (as cholecalciferol) vitamin e (as d-alpha-tocopherol acetate) vitamin b1 (as thiamine hcl) vitamin b2 (as riboflavin phosphate sodium) niacin (as niacinamide) vitamin b6 (pyridoxine hcl) folate (as 69 mcg quatrefolic ((6s)-5 methyltetrahydrofolate, glucosamine salt, molar equivalent to 37.5 mcg of folic acid)) vitamin b12 (as cyanocobalamin) fluoride (as sodium fluoride) solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:81279-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A450 ug  in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID36 mg  in 1 mL
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug  in 1 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL3.35 mg  in 1 mL
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE0.5 mg  in 1 mL
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN0.6 mg  in 1 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE4 mg  in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE0.4 mg  in 1 mL
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID117 ug  in 1 mL
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN2 ug  in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POTASSIUM CARBONATE (UNII: BQN1B9B9HA)  
.ALPHA.-D-GLUCURONIC ACID (UNII: M7Y086VB5G)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorgrapeImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81279-100-501 in 1 CARTON12/20/2023
150 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/20/2023
Labeler - Pangea Pharmaceuticals, LLC (117751012)

Revised: 12/2023
Document Id: 25d8122d-c1b4-4da3-98cf-0012d79e17cc
Set id: 263e77a5-4d0e-4cec-b2d8-04fd28ce3338
Version: 1
Effective Time: 20231222
 
Pangea Pharmaceuticals, LLC