DailyMed - 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

NHRIC Code(s): 44946-2017-8, 44946-2018-8
Packager: Sancilio & Company, Inc.

Category: DIETARY SUPPLEMENT

Drug Label Information

Updated April 11, 2018

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STATEMENT OF IDENTITY

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.
HEALTH CLAIM

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

INGREDIENTS AND APPEARANCE

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	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:44946-2017
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T)	Vitamin A	1500 [iU] in 1 mL
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	35 mg in 1 mL
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU] in 1 mL
TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8)	TOCOPHEROL	5 [iU] in 1 mL
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	0.5 mg in 1 mL
RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E)	FLAVIN MONONUCLEOTIDE	0.6 mg in 1 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	8 mg in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	0.4 mg in 1 mL
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	2 ug in 1 mL
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Sodium Hydroxide (UNII: 55X04QC32I)
Sucralose (UNII: 96K6UQ3ZD4)
Methylparaben (UNII: A2I8C7HI9T)
Caramel (UNII: T9D99G2B1R)
Sodium Benzoate (UNII: OJ245FE5EU)
Sulfuric Acid (UNII: O40UQP6WCF)
Ferrous Sulfate (UNII: 39R4TAN1VT)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NHRIC:44946-2017-8	50 mL in 1 BOTTLE, DROPPER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Dietary Supplement		08/24/2017

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:44946-2018
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T)	Vitamin A	1500 [iU] in 1 mL
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	35 mg in 1 mL
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU] in 1 mL
TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8)	TOCOPHEROL	5 [iU] in 1 mL
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	0.5 mg in 1 mL
RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E)	FLAVIN MONONUCLEOTIDE	0.6 mg in 1 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	8 mg in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	0.4 mg in 1 mL
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	2 ug in 1 mL
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Sodium Hydroxide (UNII: 55X04QC32I)
Sucralose (UNII: 96K6UQ3ZD4)
Methylparaben (UNII: A2I8C7HI9T)
Caramel (UNII: T9D99G2B1R)
Sodium Benzoate (UNII: OJ245FE5EU)
Sulfuric Acid (UNII: O40UQP6WCF)
Ferrous Sulfate (UNII: 39R4TAN1VT)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NHRIC:44946-2018-8	50 mL in 1 BOTTLE, DROPPER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Dietary Supplement		08/24/2017

Labeler - Sancilio & Company, Inc. (176681257)

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Published Date (What is this?)	Version	Files
Apr 12, 2018	3 (current)	download
Apr 11, 2018	2	download
Sep 12, 2017	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1234482	ascorbic acid 35 MG/ML / cholecalciferol 400 UNT/ML / niacin 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / thiamine 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution	SCD
2	1234482	ascorbic acid 35 MG / cholecalciferol 400 UNT / niacin 8 MG / riboflavin 0.6 MG / sodium fluoride 0.55 MG (fluoride 0.25 MG) / thiamine 0.5 MG / vitamin A 1500 UNT / vitamin B 12 2 MCG / vitamin B6 0.4 MG / vitamin E 5 UNT per ML Oral Solution	SY
3	1234482	vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution	SY
4	1234482	vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution	SY
5	1234482	vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution	SY
6	1234482	vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution	SY
7	1234482	vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution	SY
8	1234482	vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution	SY
9	1234482	vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution	SY
10	1234482	vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution	SY
11	1234482	vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution	SY
12	1234482	vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution	SY
13	1234482	vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution	SY
14	1234482	vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution	SY

RxCUI

RxNorm NAME

RxTTY

1234482

ascorbic acid 35 MG/ML / cholecalciferol 400 UNT/ML / niacin 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / thiamine 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution

SCD

1234482

ascorbic acid 35 MG / cholecalciferol 400 UNT / niacin 8 MG / riboflavin 0.6 MG / sodium fluoride 0.55 MG (fluoride 0.25 MG) / thiamine 0.5 MG / vitamin A 1500 UNT / vitamin B 12 2 MCG / vitamin B6 0.4 MG / vitamin E 5 UNT per ML Oral Solution

1234482

vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution

1234482

vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution

1234482

vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution

1234482

vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution

1234482

vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution

1234482

vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution

1234482

vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution

1234482

vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution

1234482

vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution

1234482

vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution

1234482

vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution

1234482

vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral Solution

Label: 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

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Label: 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

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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

Number of versions: 3

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

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

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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

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.