Quflora Pediatric
Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolic Acid, Folic Acid, Cyanocobalamin, Magnesium Oxide, Cupric Sulfate, And Sodium Fluoride
Carwin Pharmaceutical Associates, Llc
Human Prescription Drug
NDC 15370-104Quflora Pediatric also known as Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolic Acid, Folic Acid, Cyanocobalamin, Magnesium Oxide, Cupric Sulfate, And Sodium Fluoride is a human prescription drug labeled by 'Carwin Pharmaceutical Associates, Llc'. National Drug Code (NDC) number for Quflora Pediatric is 15370-104. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Quflora Pediatric drug includes .alpha.-tocopherol, Dl- - 15 [iU]/1 Ascorbic Acid - 60 mg/1 Cholecalciferol - 400 [iU]/1 Cupric Sulfate - 1 mg/1 Cyanocobalamin - 4 ug/1 Folic Acid - 100 ug/1 Levomefolic Acid - 108 ug/1 Magnesium Oxide - 15 mg/1 Niacinamide - 5 mg/1 Pyridoxine Hydrochloride - 1.5 mg/1 and more. The currest status of Quflora Pediatric drug is Active.
Drug Information:
| Drug NDC: | 15370-104 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Quflora Pediatric |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolic Acid, Folic Acid, Cyanocobalamin, Magnesium Oxide, Cupric Sulfate, And Sodium Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Carwin Pharmaceutical Associates, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Chewable |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | .ALPHA.-TOCOPHEROL, DL- - 15 [iU]/1
ASCORBIC ACID - 60 mg/1
CHOLECALCIFEROL - 400 [iU]/1
CUPRIC SULFATE - 1 mg/1
CYANOCOBALAMIN - 4 ug/1
FOLIC ACID - 100 ug/1
LEVOMEFOLIC ACID - 108 ug/1
MAGNESIUM OXIDE - 15 mg/1
NIACINAMIDE - 5 mg/1
PYRIDOXINE HYDROCHLORIDE - 1.5 mg/1
Load more...RIBOFLAVIN - 1.3 mg/1
SODIUM FLUORIDE - .5 mg/1
THIAMINE HYDROCHLORIDE - 1.2 mg/1
VITAMIN A ACETATE - 1200 [iU]/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 06 Jan, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 26 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | CarWin Pharmaceutical Associates, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | M0022797
N0000175952
N0000193618
M0001797
M0022794
N0000175951
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 25X51I8RD4
1C6V77QF41
3A3U0GI71G
7QWA1RIO01
935E97BOY8
68Y4CF58BV
8ZYQ1474W7
3LE3D9D6OY
TLM2976OFR
8S95DH25XC
Load more...M572600E5P
PQ6CK8PD0R
LRX7AJ16DT
P6YC3EG204
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Vitamin D [EPC]
Vitamin C [EPC]
Vitamin B12 [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Vitamin D [CS]
Ascorbic Acid [CS]
Vitamin B 12 [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Analogs/Derivatives [Chemical/Ingredient]
Ascorbic Acid [CS]
Calculi Dissolution Agent [EPC]
Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
Magnesium Ion Exchange Activity [MoA]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 15370-104-30 | 30 TABLET, CHEWABLE in 1 BOTTLE (15370-104-30) | 06 Jan, 2014 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Quflora pediatric vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, folic acid, cyanocobalamin, magnesium oxide, cupric sulfate, and sodium fluoride vitamin a acetate vitamin a ascorbic acid ascorbic acid cholecalciferol cholecalciferol .alpha.-tocopherol, dl- .alpha.-tocopherol, dl- thiamine hydrochloride thiamine ion thiamine riboflavin riboflavin niacinamide niacinamide pyridoxine hydrochloride pyridoxine levomefolic acid levomefolic acid folic acid folic acid cyanocobalamin cyanocobalamin magnesium oxide magnesium cation cupric sulfate cupric cation sodium fluoride fluoride ion grape citric acid monohydrate silicon dioxide magnesium stearate microcrystalline cellulose sucralose sucrose stearic acid 103 quflora pediatric vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, folic acid, cyanocobalamin, magnesium oxide, cupric sulfate, and sodium fluoride vitamin a acetate vitamin a ascorbic acid ascorbic acid cholecalciferol cholecalciferol .alpha.-tocopherol, dl- .alpha.-tocopherol, dl- thiamine hydrochloride thiamine ion thiamine riboflavin riboflavin niacinamide niacinamide pyridoxine hydrochloride pyridoxine levomefolic acid levomefolic acid folic acid folic acid cyanocobalamin cyanocobalamin magnesium oxide magnesium cation cupric sulfate cupric cation sodium fluoride fluoride ion grape citric acid monohydrate silicon dioxide magnesium stearate microcrystalline cellulose sucralose sucrose stearic acid 104 quflora pediatric vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, folic acid, cyanocobalamin, magnesium oxide, cupric sulfate, and sodium fluoride vitamin a acetate vitamin a ascorbic acid ascorbic acid cholecalciferol cholecalciferol .alpha.-tocopherol, dl- .alpha.-tocopherol, dl- thiamine hydrochloride thiamine ion thiamine riboflavin riboflavin niacinamide niacinamide pyridoxine hydrochloride pyridoxine levomefolic acid levomefolic acid folic acid folic acid cyanocobalamin cyanocobalamin magnesium oxide magnesium cation cupric sulfate cupric cation sodium fluoride fluoride ion grape citric acid monohydrate silicon dioxide magnesium stearate microcrystalline cellulose sucralose sucrose stearic acid 105
Indications and Usage:
Indications and usage quflora⢠pediatric chewable tablets with 0.5 mg fluoride is a prescription dietary fluoride supplement providing twelve essential vitamins and minerals.
Warnings:
Warnings keep out of the reach of children. in case of accidental overdose, seek professional emergency assistance or contact a poison control center immediately. this product should be chewed and is not recommended for children under age 4.
General Precautions:
General 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. incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed. your healthcare practitioner can prescribe the correct dosage.
Dosage and Administration:
Dosage and administration one tablet daily or as prescribed by your healthcare practitioner. each tablet contains 0.5 mg fluoride ion (f) from 1.1 mg sodium fluoride (naf).
Contraindications:
Contraindications quflora⢠pediatric chewable tablets with 0.5 mg fluoride should not be used by patients with a known history of hypersensitivity to any of the listed ingredients.
Adverse Reactions:
Adverse reactions allergic rash and other idiosyncrasies have been rarely reported. call your doctor for medical advice about side effects. you may report side effects or obtain product information by calling carwin pharmaceutical associates, llc at 1-844-700-5011.
Description:
Description quflora⢠pediatric chewable tablets with 0.5 mg fluoride is a yellow round tablet imprinted "104".
How Supplied:
How supplied quflora⢠pediatric chewable tablets with 0.5 mg fluoride available in child-resistant bottles of 30 (product code: 15370-104-30). rx only storage store at controlled room temperature 20° c to 25° c (68° f to 77° f), excursions permitted between 15° c and 30° c (59° f and 86° f). protect from light, moisture and excessive heat. keep this product out of reach of children.
Package Label Principal Display Panel:
Principal display panel - 0.25 mg tablet bottle label 15370-103-30 qu f lora⢠pediatric chewable tablets multivitamin with 0.25 mg fluoride each chewable tablet contains: 0.55 mg sodium fluoride, usp rx only ⢠grape flavor 30 tablets carwin pharmaceutical associates principal display panel - 0.25 mg tablet bottle label
Principal display panel - 0.5 mg tablet bottle label 15370-104-30 qu f lora⢠pediatric chewable tablets multivitamin with 0.5 mg fluoride each chewable tablet contains: 1.1 mg sodium fluoride, usp rx only ⢠grape flavor 30 tablets carwin pharmaceutical associates principal display panel - 0.5 mg tablet bottle label
Principal display panel - 1 mg tablet bottle label 15370-105-30 qu f lora⢠pediatric chewable tablets multivitamin with 1 mg fluoride each chewable tablet contains: 2.2 mg sodium fluoride, usp rx only ⢠grape flavor 30 tablets carwin pharmaceutical associates principal display panel - 1 mg tablet bottle label