SODIUM FLUORIDE AND VITAMIN D DROPS- cholecalciferol and sodium fluoride liquid 
CARWIN PHARMACEUTICAL ASSOCIATES, LLC

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Sodium Fluoride - Vitamin D Liquid Drops

Supplement Facts
Servings Size: 1 mL (Mark on dropper)
Serving per Container: 50
Amount per serving% Daily Value
*
Daily Value not established.
Vitamin D400 IU100%
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.

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

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.

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

Image

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

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

Principal Display Panel - 50 mL Bottle Box
SODIUM FLUORIDE AND VITAMIN D DROPS 
cholecalciferol and sodium fluoride liquid
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:15370-106
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]  in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:15370-106-501 in 1 BOX
150 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT10/30/201805/16/2023
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
flavor
Labeler - CARWIN PHARMACEUTICAL ASSOCIATES, LLC (079217215)

Revised: 5/2023
Document Id: 4b18e6bc-7368-4a94-a7fd-123c40164288
Set id: 733aed69-1986-4ac4-a53f-e631016a52e5
Version: 2
Effective Time: 20230518
 
CARWIN PHARMACEUTICAL ASSOCIATES, LLC