MULTIVITAMIN WITH FLUORIDE- .alpha.-tocopherol acetate, dl-, ascorbic acid, cyanocobalamin, sodium fluoride, folic acid, niacin, pyridoxine, riboflavin, thiamine, vitamin a, and vitamin d tablet, chewable 
A-S Medication Solutions

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.

----------

Multivitamin with Fluoride
Chewable Tablets

Each Multivitamin with 0.5 mg Fluoride Tablet Contains:

*
Each Multivitamin with 0.5 mg Fluoride Tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride (NaF).
Vitamin A (as Acetate)2500 IU
Vitamin C60 mg
Vitamin D400 IU
Vitamin E15 IU
Thiamine1.05 mg
Riboflavin1.2 mg
Niacin13.5 mg
Vitamin B61.05 mg
Folate (as Folic Acid)0.3 mg
Vitamin B124.5 mcg
Fluoride (as Sodium Fluoride)*0.5 mg

WARNING

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222. TABLET SHOULD BE CHEWED. THIS PRODUCT, AS WITH ALL CHEWABLE TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE 4 DUE TO RISK OF CHOKING.

DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING

Directions

USE AS DIRECTED BY YOUR PHYSICIAN.

Description

Off-white to pale yellow, speckled, fruit flavor, round-shaped chewable tablet debossed "SCI" on one side and "5" on the other.

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 (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.

Other Ingredients

Xylitol, microcrystalline cellulose, mannitol, talc, magnesium stearate, sucralose, natural fruit flavor, citric acid.

Storage

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

This medical food product is formulated to be administered orally, under the ongoing supervision of a physician and is intended for the dietary management of dental caries for which a distinctive nutritional requirement of fluoride, based on recognized scientific principles, has been established by medical evaluation.

The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health-insurance and state level reimbursement programs and is not intended to denote registration with the FDA.

Manufactured by: Sancilio & Co., Inc.
Riviera Beach, FL 33404 USA

rev. 11/18/11

HOW SUPPLIED

Product: 50090-0435

NDC: 50090-0435-1 100 TABLET, CHEWABLE in a BOTTLE, PLASTIC

.Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, and Vitamin D

Label Image
MULTIVITAMIN WITH FLUORIDE 
.alpha.-tocopherol acetate, dl-, ascorbic acid, cyanocobalamin, sodium fluoride, folic acid, niacin, pyridoxine, riboflavin, thiamine, vitamin a, and vitamin d tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50090-0435(NDC:44946-1024)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-15 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN4.5 ug
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID0.3 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN13.5 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE1.05 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.2 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.05 mg
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A2500 [iU]
VITAMIN D (UNII: 9VU1KI44GP) (VITAMIN D - UNII:9VU1KI44GP) VITAMIN D400 [iU]
Inactive Ingredients
Ingredient NameStrength
Xylitol (UNII: VCQ006KQ1E)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Mannitol (UNII: 3OWL53L36A)  
Talc (UNII: 7SEV7J4R1U)  
Magnesium stearate (UNII: 70097M6I30)  
Sucralose (UNII: 96K6UQ3ZD4)  
Anhydrous Citric acid (UNII: XF417D3PSL)  
Product Characteristics
ColorWHITE (Off-white to pale yellow speckled) Scoreno score
ShapeROUNDSize13mm
FlavorFRUITImprint Code SCI;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-0435-1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/29/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/20/2011
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-0435)

Revised: 10/2017
Document Id: 65079180-0dee-4058-8de8-07bac3b747a2
Set id: 8f9e5547-67ad-43c9-ab35-b4c2c1f3b01f
Version: 5
Effective Time: 20171005
 
A-S Medication Solutions