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NDC 52796-0173-12 Floriva 20; 75; 1000; 40; 600; 1; 6; 100; 162; 15; 1.8; 1.5; .25; 1.3; 1000; 5 [iU]/1; mg/1; [iU]/1; ug/1; [iU]/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Details
Floriva 20; 75; 1000; 40; 600; 1; 6; 100; 162; 15; 1.8; 1.5; .25; 1.3; 1000; 5 [iU]/1; mg/1; [iU]/1; ug/1; [iU]/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1
Floriva is a ORAL TABLET, CHEWABLE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by BonGeo Pharmaceuticals, Inc.. The primary component is .ALPHA.-TOCOPHEROL; ASCORBIC ACID; BETA CAROTENE; BIOTIN; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FOLIC ACID; LEVOMEFOLATE GLUCOSAMINE; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE; VITAMIN A ACETATE; ZINC GLUCONATE.
Product Information
| NDC | 52796-0173 |
|---|---|
| Product ID | 52796-173_b2535b50-3849-4757-ada4-e9d28ec7b64b |
| Associated GPIs | 78460000000510 |
| GCN Sequence Number | 074846 |
| GCN Sequence Number Description | pedi multivit no.85/fluoride TAB CHEW 0.25(0.55) ORAL |
| HIC3 | C6H |
| HIC3 Description | PEDIATRIC VITAMIN PREPARATIONS |
| GCN | 39629 |
| HICL Sequence Number | 041545 |
| HICL Sequence Number Description | PEDIATRIC MULTIVITAMIN NO.85 WITH SODIUM FLUORIDE |
| Brand/Generic | Brand |
| Proprietary Name | Floriva |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, and SODIUM FLUORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, CHEWABLE |
| Route | ORAL |
| Active Ingredient Strength | 20; 75; 1000; 40; 600; 1; 6; 100; 162; 15; 1.8; 1.5; .25; 1.3; 1000; 5 |
| Active Ingredient Units | [iU]/1; mg/1; [iU]/1; ug/1; [iU]/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 |
| Substance Name | .ALPHA.-TOCOPHEROL; ASCORBIC ACID; BETA CAROTENE; BIOTIN; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FOLIC ACID; LEVOMEFOLATE GLUCOSAMINE; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE; VITAMIN A ACETATE; ZINC GLUCONATE |
| Labeler Name | BonGeo Pharmaceuticals, Inc. |
| Pharmaceutical Class | Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 An |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 52796-0173-12 (52796017312)
| NDC Package Code | 52796-173-12 |
|---|---|
| Billing NDC | 52796017312 |
| Package | 12 BLISTER PACK in 1 CARTON (52796-173-12) / 1 TABLET, CHEWABLE in 1 BLISTER PACK |
| Marketing Start Date | 2015-09-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 3d5fbe3a-a95b-4688-a96e-b34e6e1e868a Details
SPL UNCLASSIFIED SECTION
| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 tablet Servings Per Container: 90 | ||
| Amount per tablet | % Daily Value* | |
| Vitamin A (50% beta carotene/50% acetate) | 2000 IU | 40% |
| Vitamin C (ascorbic acid) | 75 mg | 125% |
| Vitamin D3 (cholecalciferol) | 600 IU | 150% |
| Vitamin E (dl alpha tocopherol acetate) | 20 IU | 67% |
| Vitamin B1 (thiamine) | 1.3 mg | 87% |
| Vitamin B2 (riboflavin) | 1.5 mg | 88% |
| Niacin (nicotinamide) | 15 mg | 75% |
| Vitamin B6 (pyridoxine) | 1.8 mg | 90% |
| Folate (as 300 mcg Quatrefolic R ((6S-5-methyltetrahydrofolic acid, glucosamine salt†, molar equivalent to 162 mcg of folic acid) and 100 mcg of folic acid) Quatrefolic CAS #: 1181972-37-1 | 262 mcg | 66% |
| Vitamin B12 (cyanocobalamin) | 6 mcg | 100% |
| Biotin | 40 mcg | 13% |
| Zinc (zinc gluconate) | 5 mg | 33% |
| Copper (cupric oxide) | 1 mg | 50% |
| Fluoride (sodium fluoride) | 0.25 mg | † |
Other Ingredients
Description
WARNING
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 INFORMATION
You may report serious side effects to 1-844-640-7607. Store in a cool, dry place at room temperature 20-25° Celsius (68-77° Fahrenheit) away from heat and sunlight. Store in original container.
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.
The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label
0.25 mg* FLUORIDE
MULTIVITAMIN TABLETS
BonGeo™
PHARMACEUTICALS
52796-173-90
Floriva™
.25 mg TABLETS
Chewable Fluoride Multivitamin
Quatrefolic®
Patent Ref.: U.S. Patent No. 7,947,662;
Other patents pending
Natural Berry Flavor
Rx Dietary Supplement
90 Chewable Tablets
*contains 0.25 mg fluoride
from .55 mg sodium fluoride
SUGAR FREE AND GLUTEN FREE
NO ARTIFICIAL COLORS OR DYES
INGREDIENTS AND APPEARANCE
| FLORIVA
vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine, riboflavin, niacinamide, pyridoxine, levomefolate glucosamine, folic acid, cyanocobalamin, biotin, zinc gluconate, cupric oxide, and sodium fluoride tablet, chewable |
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| Labeler - BonGeo Pharmaceuticals, Inc. (964822022) |