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Multi-Vit with Fluoride Drops

Generic Name: multi-vitamin with fluoride
Dosage Form: oral solution/drops

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.

Supplement Facts
Serving Size: 1 mL
Servings Per Container: 50
Amount per serving % Daily Value*
Percent Daily Value (%DV) based on a 2,000 calorie diet.
*
Daily Value for children 6 months to 4 years old.
Daily Value not established.
Vitamin A 1,500 IU 60
Vitamin C 35 mg 88
Vitamin D 400 IU 100
Vitamin E 5 IU 50
Thiamine 0.5 mg 71
Riboflavin 0.6 mg 75
Niacin 8 mg 89
Vitamin B6 0.4 mg 57
Vitamin B12 2 mcg 67
Fluoride (as Sodium Fluoride) 0.5 mg

Ingredients: Purified Water, Glycerin, Propylene Glycol, Ascorbic Acid, Polysorbate 80, Niacinamide, Sucralose, Sodium Hydroxide, D-Alpha-Tocopheryl Acid Succinate, Natural Grape Flavor, Caramel Color, Methyl Paraben, Sodium Benzoate, Sodium Fluoride, Vitamin A Palmitate, Riboflavin 5 Phosphate Sodium, Ferrous Sulfate, Thiamine Hydrochloride, Pyridoxine Hydrochloride, Sulfuric Acid, Cholecalciferol, Cyanocobalamin.

Warning

KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222.

SHAKE WELL BEFORE USING

DIRECTIONS

Use as directed by a physician.

How to Use

Fill dropper to appropriate line and dispense with a single squeeze of the dropper bulb. The full dose will be given. It is normal for a small amount to remain in the tip of the dropper.

Storage

Store in a cool, dry place at room temperature 20°-25°C (68°-77°F) away from heat and direct sunlight. Store in the original container.

Manufactured by:
Sancilio & Company, Inc.
3874 Fiscal Court
Riviera Beach, FL 33404
(800)SCI-8711

REV 001 8/28/17

Made in the USA

PRINCIPAL DISPLAY PANEL - 0.25 mg/mL Bottle Label

44946-2017-08

SCI
Sancilio & Company, Inc.
Developing Good Science into Great Medicine®

Multivitamin Drops
with Fluoride

*Each 1 mL provides 0.25 mg Fluoride

NO DYES OR SUGAR
SACCHARIN AND GLUTEN FREE

0.25*
mg/mL

1 ⅔ FL. OZ. (50 mL)

Dietary
Supplement

Dispense under a
physician's order

PRINCIPAL DISPLAY PANEL - 0.5 mg/mL Bottle Label

44946-2018-08

SCI
Sancilio & Company, Inc.
Developing Good Science into Great Medicine®

Multivitamin Drops
with Fluoride

*Each 1 mL provides 0.5 mg Fluoride

NO DYES OR SUGAR
SACCHARIN AND GLUTEN FREE

0.5*
mg/mL

1 ⅔ FL. OZ. (50 mL)

Dietary
Supplement

Dispense under a
physician's order

MULTIVITAMIN DROPS WITH FLUORIDE 
vitamin a palmitate, ascorbic acid, cholecalciferol, tocopherol, thiamine hydrochloride, riboflavin 5-phosphate sodium, niacinamide, pyridoxine hydrochloride, cyanocobalamin, and sodium fluoride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44946-2017
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vitamin A Palmitate (Vitamin A) Vitamin A 1500 [iU]  in 1 mL
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 35 mg  in 1 mL
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]  in 1 mL
TOCOPHEROL (TOCOPHEROL) TOCOPHEROL 5 [iU]  in 1 mL
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 0.5 mg  in 1 mL
RIBOFLAVIN 5'-PHOSPHATE SODIUM (FLAVIN MONONUCLEOTIDE) FLAVIN MONONUCLEOTIDE 0.6 mg  in 1 mL
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 8 mg  in 1 mL
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 0.4 mg  in 1 mL
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 2 ug  in 1 mL
Sodium Fluoride (FLUORIDE ION) FLUORIDE ION 0.25 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Glycerin  
Propylene Glycol  
Polysorbate 80  
Sodium Hydroxide  
Sucralose  
Methylparaben  
Caramel  
Sodium Benzoate  
Sulfuric Acid  
Ferrous Sulfate  
Packaging
# Item Code Package Description
1 NDC:44946-2017-8 50 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/24/2017
MULTIVITAMIN DROPS WITH FLUORIDE 
vitamin a palmitate, ascorbic acid, cholecalciferol, tocopherol, thiamine hydrochloride, riboflavin 5-phosphate sodium, niacinamide, pyridoxine hydrochloride, cyanocobalamin, and sodium fluoride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44946-2018
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vitamin A Palmitate (Vitamin A) Vitamin A 1500 [iU]  in 1 mL
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 35 mg  in 1 mL
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]  in 1 mL
TOCOPHEROL (TOCOPHEROL) TOCOPHEROL 5 [iU]  in 1 mL
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 0.5 mg  in 1 mL
RIBOFLAVIN 5'-PHOSPHATE SODIUM (FLAVIN MONONUCLEOTIDE) FLAVIN MONONUCLEOTIDE 0.6 mg  in 1 mL
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 8 mg  in 1 mL
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 0.4 mg  in 1 mL
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 2 ug  in 1 mL
Sodium Fluoride (FLUORIDE ION) FLUORIDE ION 0.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Glycerin  
Propylene Glycol  
Polysorbate 80  
Sodium Hydroxide  
Sucralose  
Methylparaben  
Caramel  
Sodium Benzoate  
Sulfuric Acid  
Ferrous Sulfate  
Packaging
# Item Code Package Description
1 NDC:44946-2018-8 50 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/24/2017
Labeler - Sancilio & Company, Inc. (176681257)
Revised: 09/2017
 
Sancilio & Company, Inc.
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