Label: FLORAFOL- multivitamin and fluoride supplement tablet
- NDC Code(s): 81279-102-30
- Packager: Pangea Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated August 15, 2024
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- Florafol™
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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 olderVitamin 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
- DOSAGE & ADMINISTRATION
- SAFE HANDLING WARNING
- PRINCIPAL DISPLAY PANEL - Multivitamin with 0.5 mg of Fluoride
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INGREDIENTS AND APPEARANCE
FLORAFOL
multivitamin and fluoride supplement tabletProduct 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 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 Labeler - Pangea Pharmaceuticals, LLC (117751012) Registrant - Pangea Pharmaceuticals, LLC (117751012)
