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NDC 15370-0102-50 Quflora FE Pediatric Drops 5; 36; 3; 400; 2; 9.5; 37.5; 4; 1; .4; .6; .25; .5; 1500 [iU]/mL; mg/mL; ug/mL; [iU]/mL; ug/mL; mg/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Details
Quflora FE Pediatric Drops 5; 36; 3; 400; 2; 9.5; 37.5; 4; 1; .4; .6; .25; .5; 1500 [iU]/mL; mg/mL; ug/mL; [iU]/mL; ug/mL; mg/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL
Quflora FE Pediatric Drops is a ORAL LIQUID in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Carwin Pharmaceutical Associates, LLC. The primary component is .ALPHA.-TOCOPHEROL ACETATE, D-; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; FERROUS SULFATE; LEVOMEFOLATE GLUCOSAMINE; NIACINAMIDE; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALM.
Product Information
| NDC | 15370-0102 |
|---|---|
| Product ID | 15370-102_a843f709-c7ea-456b-8bdc-48901d1fd2d2 |
| Associated GPIs | 78450000000915 |
| GCN Sequence Number | 077359 |
| GCN Sequence Number Description | ped multivit 151/iron/fluoride DROPS 9.5-.25/ML ORAL |
| HIC3 | C6H |
| HIC3 Description | PEDIATRIC VITAMIN PREPARATIONS |
| GCN | 43343 |
| HICL Sequence Number | 044236 |
| HICL Sequence Number Description | PEDIATRIC MULTIVITAMIN NO.151/FERROUS SULFATE/SOD FLUORIDE |
| Brand/Generic | Brand |
| Proprietary Name | Quflora FE Pediatric Drops |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PANTOTHENIC ACID, PYRIDOXINE HYDROCHLORIDE, BIOTIN, LEVOMEFOLATE GLUCOSAMINE, CYANOCOBALAMIN, FERROUS SULFATE, and SODIUM |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 5; 36; 3; 400; 2; 9.5; 37.5; 4; 1; .4; .6; .25; .5; 1500 |
| Active Ingredient Units | [iU]/mL; mg/mL; ug/mL; [iU]/mL; ug/mL; mg/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL |
| Substance Name | .ALPHA.-TOCOPHEROL ACETATE, D-; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; FERROUS SULFATE; LEVOMEFOLATE GLUCOSAMINE; NIACINAMIDE; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALM |
| Labeler Name | Carwin Pharmaceutical Associates, LLC |
| Pharmaceutical Class | Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 15370-0102-50 (15370010250)
| NDC Package Code | 15370-102-50 |
|---|---|
| Billing NDC | 15370010250 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (15370-102-50) / 50 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2017-04-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL feb95882-69f1-4f30-91aa-505f45f3ab3f Details
SPL UNCLASSIFIED SECTION
| Supplement Facts | |||
|---|---|---|---|
| Serving Size: 1 mL (Mark on dropper) | |||
| Servings per Container: 50 | |||
| Amount Per 1 mL | % DV Children 6 months to under 4 years of age | % DV for Adults and Children 4 or more years of age | |
|
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| Vitamin A (as Palmitate) | 1500 IU | 60% | 30% |
| Vitamin C (as Ascorbic Acid) | 36 mg | 90% | 60% |
| Vitamin D3 (as Cholecalciferol) | 400 IU | 100% | 100% |
| Vitamin E (as D-Alpha-Tocopheryl Acetate) | 5 IU | 50% | 17% |
| Thiamin (as Thiamine HCl, Vitamin B1) | 0.5 mg | 71% | 33% |
| Riboflavin (Vitamin B2) | 0.6 mg | 75% | 35% |
| Niacin (as Niacinamide) | 4 mg | 45% | 20% |
| Pantothenic Acid | 1 mg | 20% | 10% |
| Vitamin B6 (as Pyridoxine HCl) | 0.4 mg | 57% | 20% |
| Biotin | 3 mcg | 2% | 1% |
| Folate (as 69 mcg Quatrefolic® ((6S)-5 Methyltetrahydrofolic acid, glucosamine salt, molar equivalent to 37.5 mcg of Folic Acid)) | 37.5 mcg | 20% | 10% |
| Vitamin B12 (as Cyanocobalamin) | 2 mcg | 67% | 33% |
| Iron (as Ferrous Sulfate) | 9.5 mg | 95% | 53% |
| Fluoride (as Sodium Fluoride) | 0.25 mg | * | * |
Other Ingredients: Purified Water, Citric Acid, Glycerin, Grape Flavor, Sorbitol, Propylene Glycol, Sucralose, Sodium Benzoate.
INDICATIONS AND USAGE
CONTRAINDICATIONS
PRECAUTIONS
General
Do not use this product if you are allergic to any of the ingredients. The suggested dose should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride. Do not eat or drink dairy products within one hour of fluoride administration since these may decrease effectiveness.
Folic Acid
Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
DOSAGE AND ADMINISTRATION
See schedule below to determine dosage. Administer orally as prescribed by a healthcare practitioner. Use with calibrated dropper for measuring doses. Each dropper full 1mL contains: 0.55 mg sodium fluoride, USP.
| Age | Less than 0.3ppm | 0.3-0.6 ppm | Greater than 0.6 ppm |
|---|---|---|---|
| Birth-6 months | None | None | None |
| 6 months-3 years | 0.25 mg/day† | None | None |
| 3-6 years | 0.50 mg/day† | 0.25 mg/day | None |
| 6-16 years | 1.0 mg/day | 0.50 mg/day | None |
Dietary Fluoride Supplement dosing schedule approved by the American Dental Association (ADA), American Academy of Pediatrics (AAP) & American Academy of Pediatric Dentistry (AAPD).
HOW SUPPLIED
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| QUFLORA FE PEDIATRIC DROPS
vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacinamide, pantothenic acid, pyridoxine hydrochloride, biotin, levomefolate glucosamine, cyanocobalamin, ferrous sulfate, and sodium fluoride liquid |
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| Labeler - Carwin Pharmaceutical Associates, LLC (079217215) |
Revised: 4/2017
Document Id: a843f709-c7ea-456b-8bdc-48901d1fd2d2
Set id: feb95882-69f1-4f30-91aa-505f45f3ab3f
Version: 1
Effective Time: 20170419