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

Carwin Pharmaceutical Associates, Llc
Human Prescription Drug
NDC 15370-102

Quflora Fe Pediatric Drops also known as 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 is a human prescription drug labeled by 'Carwin Pharmaceutical Associates, Llc'. National Drug Code (NDC) number for Quflora Fe Pediatric Drops is 15370-102. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Quflora Fe Pediatric Drops drug includes .alpha.-tocopherol Acetate, D- - 5 [iU]/mL Ascorbic Acid - 36 mg/mL Biotin - 3 ug/mL Cholecalciferol - 400 [iU]/mL Cyanocobalamin - 2 ug/mL Ferrous Sulfate - 9.5 mg/mL Levomefolate Glucosamine - 37.5 ug/mL Niacinamide - 4 mg/mL Pantothenic Acid - 1 mg/mL Pyridoxine Hydrochloride - .4 mg/mL and more. The currest status of Quflora Fe Pediatric Drops drug is Active.

Drug Information:

Drug NDC:	15370-102
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 Fe Pediatric Drops
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 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
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:	Liquid
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 ACETATE, D- - 5 [iU]/mL ASCORBIC ACID - 36 mg/mL BIOTIN - 3 ug/mL CHOLECALCIFEROL - 400 [iU]/mL CYANOCOBALAMIN - 2 ug/mL FERROUS SULFATE - 9.5 mg/mL LEVOMEFOLATE GLUCOSAMINE - 37.5 ug/mL NIACINAMIDE - 4 mg/mL PANTOTHENIC ACID - 1 mg/mL PYRIDOXINE HYDROCHLORIDE - .4 mg/mL Load more... RIBOFLAVIN - .6 mg/mL SODIUM FLUORIDE - .25 mg/mL THIAMINE HYDROCHLORIDE - .5 mg/mL VITAMIN A PALMITATE - 1500 [iU]/mL
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:	21 Apr, 2017
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	16 Jan, 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:	N0000193618 M0001797 M0022797 N0000175952 M0022794 N0000175951
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	A7E6112E4N PQ6CK8PD0R 6SO6U10H04 1C6V77QF41 P6YC3EG204 39R4TAN1VT Q65PL71Q1A 25X51I8RD4 19F5HK2737 68Y4CF58BV Load more... TLM2976OFR 8ZYQ1474W7 M572600E5P 1D1K0N0VVC
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 C [EPC] Vitamin D [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:	Ascorbic Acid [CS] Vitamin D [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] 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
15370-102-50	1 BOTTLE, DROPPER in 1 CARTON (15370-102-50) / 50 mL in 1 BOTTLE, DROPPER	21 Apr, 2017	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.

Other medicines with the same generic name

Quflora Fe Pediatric Drops

Vitamin A Palmitate & more..

Liquid
Carwin Pharmaceutical Associates, LLC
NDC: 15370-102

Product Elements:

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 vitamin a palmitate vitamin a retinol ascorbic acid ascorbic acid cholecalciferol cholecalciferol .alpha.-tocopherol acetate, d- .alpha.-tocopherol, d- thiamine hydrochloride thiamine ion thiamine riboflavin riboflavin niacinamide niacinamide pantothenic acid pantothenic acid pyridoxine hydrochloride pyridoxine biotin biotin levomefolate glucosamine levomefolate glucosamine cyanocobalamin cyanocobalamin ferrous sulfate ferrous cation sodium fluoride fluoride ion water citric acid monohydrate glycerin sorbitol propylene sucralose sodium benzoate

Boxed Warning:

Warning accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. keep this product out of reach of children. in case of accidental overdose, call a doctor or poison control center immediately.

Indications and Usage:

Indications and usage quflora Â® fe pediatric liquid drops is a prescription dietary supplement providing essential vitamins, iron and fluoride.

General 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.

Dosage and Administration:

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. fluoride ion level in drinking water (ppm) 1.0 part per million (ppm) = 1 milligram/liter (mg/l) 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 2.2 mg sodium fluoride contains 1 mg fluoride ion 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).

Contraindications:

Contraindications do not use in areas where drinking water exceeds 0.6 ppm f. do not administer to pediatric patients less than 6 months old.

Description:

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 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 Â® ((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 daily value not established other ingredients: purified water, citric acid, glycerin, grape flavor, sorbitol, propylene glycol, sucralose, sodium benzoate.

Description quflora Â® fe pediatric liquid drops is a yellow, dye free, grape flavored liquid.

How Supplied:

How supplied quflora Â® fe pediatric liquid drops in a 50 ml (1 â fl. oz.) child-resistant bottle with accompanying calibrated dropper. (product code: 15370-102-50). rx only storage store in a cool, dry place at room temperature 20Â°c to 25Â°c (68Â°f to 77Â°f) away from heat and sunlight. shake well before using

Package Label Principal Display Panel:

Principal display panel - 50 ml bottle carton 15370-102-50 qu f lora Â® fe pediatric liquid drops dietary supplement with iron & 0.25 mg/ml fluoride rx only â¢ grape flavor 50 ml (1â fl oz.) carwin pharmaceutical associates quatrefolic Â® principal display panel - 50 ml bottle carton

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.