Label: POLY-VI-FLOR- multivitamin and fluoride supplement suspension/ drops
- NHRIC Code(s): 23594-550-50
- Packager: Aytu Therapeutics LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated March 27, 2023
If you are a consumer or patient please visit this version.
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Poly-Vi-Flor
(Multivitamin with 0.25 mg of Fluoride)
Poly-Vi-Flor Drop are specifically designed to help meet the nutritional needs of your growing infant or toddler.
- Poly-Vi-Flor Drops are the ideal vitamin supplement during your child's transition to solid foods, during growth spurts, or for the picky eater.
- One daily dose of Poly-Vi-Flor Drops provides 7 essential vitamins and is fruit flavored.
- Drops are dye-free and gluten-free.
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Health Claim
Multivitamin and Fluoride Supplement
Supplement Facts
Serving Size 1 mL • Servings Per Container 50% Daily Value Amount Per 1 mL Infants
through
12 monthsChildren
1 through 3
years of agevitamin D (as cholecalciferol) 10 mcg 100% 67% vitamin E (as d-alpha-tocopheryl acetate) 3.35 mg 67% 56% niacin (as niacinamide) 8 mg 200% 133% vitamin B6 (as pyridoxine HCl) 0.4 mg 133% 80% folate (from Metafolin®) 200 mcg DFE 250% 133% fluoride (as sodium fluoride) 0.25 mg * * *Daily Value not established
Ingredients: Glycerin, Water, Fructose, Ascorbic Acid, Polysorbate 80, Natural Flavoring, Soy Lecithin, Potassium Sorbate
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Dosage and Administration
How to Use the Enclosed Dropper
Fill the dropper to the 1 mL line to provide the full daily dosage. Use full dosage, regardless of age or weight, unless your child's doctor recommends a different dosage.
Dispense with a single squeeze of the dropper bulb. It is normal for a small amount to remain in the tip.
Dosing Tips
Drops may be given by dispensing directly into the mouth. Drops may also be mixed with formula, fruit juice, cereal or other foods to increase your child's acceptance.
Shake well before use.
This product comes with a child-resistant cap. Refrigeration not required. After opening, store away from direct sunlight.
- Warning
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Principal Display Panel
PRINCIPAL DISPLAY PANEL - Poly-Vi-Flor with 0.25 mg of Fluoride
23594-550-50
Poly-Vi-Flor®
Essential Vitamins for Infants & Toddlers
FRUITY FLAVOR
MULTIVITAMIN AND FLUORIDE SUPPLEMENT
0.25 mg
NOT SUBSTITUTABLE
CONTAINS: METAFOLIN
1 2/3 FL OZ (50 mL)
Aytu BioPharma
Dispense under a physician’s order
Bottle Label
Carton Label
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INGREDIENTS AND APPEARANCE
POLY-VI-FLOR
multivitamin and fluoride supplement suspension/ dropsProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:23594-550 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 10 ug in 1 mL .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 3.35 mg in 1 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 8 mg in 1 mL PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 0.4 mg in 1 mL LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 200 ug in 1 mL SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) FRUCTOSE (UNII: 6YSS42VSEV) ASCORBIC ACID (UNII: PQ6CK8PD0R) POLYSORBATE 80 (UNII: 6OZP39ZG8H) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:23594-550-50 1 in 1 PACKAGE 1 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 12/23/2022 Labeler - Aytu Therapeutics LLC (117244733)