| NDC | 50090-0435-1 |
| Set ID | 8f9e5547-67ad-43c9-ab35-b4c2c1f3b01f |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | A-S Medication Solutions |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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DESCRIPTION
Each Multivitamin with 0.5 mg Fluoride Tablet Contains:
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- 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 C 60 mg Vitamin D 400 IU Vitamin E 15 IU Thiamine 1.05 mg Riboflavin 1.2 mg Niacin 13.5 mg Vitamin B6 1.05 mg Folate (as Folic Acid) 0.3 mg Vitamin B12 4.5 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
- Description
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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
- Storage
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SPL UNCLASSIFIED SECTION
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 USArev. 11/18/11
- HOW SUPPLIED
- .Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, and Vitamin D
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INGREDIENTS AND APPEARANCE
MULTIVITAMIN WITH FLUORIDE
.alpha.-tocopherol acetate, dl-, ascorbic acid, cyanocobalamin, sodium fluoride, folic acid, niacin, pyridoxine, riboflavin, thiamine, vitamin a, and vitamin d tablet, chewableProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0435(NDC:44946-1024) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength .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 ACID 60 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 4.5 ug SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 0.3 mg NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 13.5 mg PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 1.05 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.2 mg THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.05 mg VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 2500 [iU] VITAMIN D (UNII: 9VU1KI44GP) (VITAMIN D - UNII:9VU1KI44GP) VITAMIN D 400 [iU] Inactive Ingredients Ingredient Name Strength 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 Color WHITE (Off-white to pale yellow speckled) Score no score Shape ROUND Size 13mm Flavor FRUIT Imprint Code SCI;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-0435-1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/29/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 12/20/2011 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-0435)
