SODIUM FLUORIDE AND VITAMIN D DROPS- cholecalciferol and sodium fluoride liquid

SODIUM FLUORIDE AND VITAMIN D DROPS by

Drug Labeling and Warnings

SODIUM FLUORIDE AND VITAMIN D DROPS by is a Other medication manufactured, distributed, or labeled by CARWIN PHARMACEUTICAL ASSOCIATES, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Supplement Facts
Servings Size: 1 mL (Mark on dropper)
Serving per Container: 50
	Amount per serving	% Daily Value
* Daily Value not established.
Vitamin D	400 IU	100%
Fluoride (as Sodium Fluoride)	0.25 mg	*

Other Ingredients: Citric acid, caramel color, glycerin, polysorbate 80, potassium sorbate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, strawberry flavor, sucralose, xanthan gum.

HEALTH CLAIM

Store at controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from light, moisture and heat.

WARNINGS

KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POSION CONTROL CENTER IMMEDIATELY AT 1-800-222-1222.

HEALTH CLAIM

Call your doctor for medical advice about side effects. To report Suspected Adverse Reactions, contact the FDA at 1–800–332–1088.

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 or aluminum/magnesium hydroxide since these may decrease effectiveness.

Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Contains 0.25 mg fluoride ion (F) from 0.55 mg sodium fluoride (NaF).

DESCRIPTION

Brown, dye free, fruit flavored liquid.

DIRECTIONS

Administer orally as prescribed by a healthcare practitioner.

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.

Do not use if seal is broken or missing from bottle.

SHAKE BEFORE USING

HEALTH CLAIM

Manufactured for:
Carwin Pharmaceutical Associates, LLC
Hazlet, NJ 07730

HEALTH CLAIM

Lot:

Exp:

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Box

15370-106-50

Sodium Fluoride - Vitamin D
Liquid Drops

FLUORIDE AND VITAMIN D DROPS

SUGAR FREE AND GLUTEN FREE

0.25
mg/mL*

*Each 1 mL provides 0.25 mg Fluoride

Rx Only
1 2/3 FL. OZ (50mL)
Fruit Flavor

Dietary Supplement

INGREDIENTS AND APPEARANCE

SODIUM FLUORIDE AND VITAMIN D DROPS 
cholecalciferol and sodium fluoride liquid

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:15370-106
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]  in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:15370-106-50	1 in 1 BOX
1		50 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		10/30/2018

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
flavor

Labeler - CARWIN PHARMACEUTICAL ASSOCIATES, LLC (079217215)