NDC 15370-101 Quflora Pediatric Drops

Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolic Acid, Cyanocobalamin, Magnesium Oxide, Cupric Sulfate, And Sodium Fluoride

NDC Product Code 15370-101

NDC Code: 15370-101

Proprietary Name: Quflora Pediatric Drops What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolic Acid, Cyanocobalamin, Magnesium Oxide, Cupric Sulfate, And Sodium Fluoride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 15370 - Carwin Pharmaceutical Associates, Llc
    • 15370-101 - Quflora Pediatric Drops

NDC 15370-101-50

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 50 mL in 1 BOTTLE, DROPPER

NDC Product Information

Quflora Pediatric Drops with NDC 15370-101 is a a human prescription drug product labeled by Carwin Pharmaceutical Associates, Llc. The generic name of Quflora Pediatric Drops is vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, cyanocobalamin, magnesium oxide, cupric sulfate, and sodium fluoride. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Carwin Pharmaceutical Associates, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Quflora Pediatric Drops Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • VITAMIN A ACETATE 1100 [iU]/mL
  • ASCORBIC ACID 45 mg/mL
  • CHOLECALCIFEROL 400 [iU]/mL
  • .ALPHA.-TOCOPHEROL ACETATE, D- 12 [iU]/mL
  • THIAMINE HYDROCHLORIDE 1 mg/mL
  • RIBOFLAVIN 1 mg/mL
  • NIACINAMIDE 2 mg/mL
  • PYRIDOXINE HYDROCHLORIDE 1 mg/mL
  • LEVOMEFOLIC ACID 81 ug/mL
  • CYANOCOBALAMIN 3 ug/mL
  • MAGNESIUM OXIDE 12 mg/mL
  • CUPRIC SULFATE 1 mg/mL
  • SODIUM FLUORIDE .5 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GRAPE (UNII: 6X543N684K)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Vitamin A - [CS]
  • Vitamin A - [EPC] (Established Pharmacologic Class)
  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Ascorbic Acid - [CS]
  • Vitamin D - [CS]
  • Vitamin D - [EPC] (Established Pharmacologic Class)
  • Vitamin B6 Analog - [EPC] (Established Pharmacologic Class)
  • Vitamin B 6 - [Chemical/Ingredient]
  • Analogs/Derivatives - [Chemical/Ingredient]
  • Vitamin B 12 - [CS]
  • Vitamin B12 - [EPC] (Established Pharmacologic Class)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Carwin Pharmaceutical Associates, Llc
Labeler Code: 15370
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 07-15-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2018 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: E What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Quflora Pediatric Drops Product Label Images

Quflora Pediatric Drops Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Supplement FactsServing Size: 1 mLServings Per Container: 50Amount Per 1 mL% Daily Value Children 6 months to under 4 years of age% Daily Value for Adults and Children 4 or more years of ageVitamin A (as Acetate)1,100 IU44%22%Vitamin C (as Ascorbic Acid)45 mg113%75%Vitamin D3 (as Cholecalciferol)400 IU100%100%Vitamin E (as D-Alpha-Tocopheryl Acetate)12 IU120%40%Thiamin (as Thiamine HCl, Vitamin B1)1 mg143%67%Riboflavin (Vitamin B2)1 mg125%59%Niacin (as Niacinamide)2 mg22%10%Vitamin B6 (as Pyridoxine HCl)1 mg143%50%Folate (as 150 mcg Quatrefolic® ((6S)-5-methyltetrahydrofolic acid, glucosamine saltDaily Value (DV) not established, molar equivalent to 81 mcg of Folic Acid))81 mcg41%20%Vitamin B12 (as Cyanocobalamin)3 mcg100%50%Magnesium (as Magnesium Oxide)12 mg6%3%Copper (as Cupric Sulfate)1 mg100%50%Fluoride (as Sodium Fluoride)0.5 mgOther Ingredients: Purified Water, Carrageenan, Sorbitol, Propylene Glycol, Glycerin, Grape Flavor, Potassium Sorbate, Sodium Benzoate, Citric Acid and Sucralose.

Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1Manufactured for:Carwin Pharmaceutical Associates, LLCHazlet, NJ 07730CAR-101-02Rev. 5/17

Indications And Usage

Quflora® 0.5 mg/mL F* Pediatric Drops is a prescription dietary supplement providing essential vitamins, minerals and fluoride.

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

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.

Other Information

Call your doctor for medical advice about side effects. You may report serious side effects by calling Carwin Pharmaceutical Associates, LLC at 1-844-700-5011.

Warnings

Keep out of the reach of children. In case of accidental overdose, seek professional emergency assistance or contact a Poison Control Center immediately.

Dosage And Administration

See schedule below to determine dosage. Administer orally as prescribed by a healthcare practitioner. Use with calibrated dropper for measuring doses.Fluoride Ion Level In Drinking Water (ppm)1.0 part per million (ppm) = 1 milligram/liter (mg/L)AgeLess than 0.3ppm0.3-0.6 ppmGreater than 0.6 ppmBirth-6 monthsNoneNoneNone6 months-3 years0.25 mg/day2.2 mg sodium fluoride contains 1 mg fluoride ionNoneNone3-6 years0.50 mg/day0.25 mg/dayNone6-16 years1.0 mg/day0.50 mg/dayNoneDietary Fluoride Supplement dosing schedule approved by the American Dental Association (ADA), American Academy of Pediatrics (AAP) & American Academy of Pediatric Dentistry (AAPD).

Description

Quflora® 0.5 mg/mL F* Pediatric Drops is a light brown, dye free, grape flavored liquid.

How Supplied

Quflora® 0.5 mg/mL F* Pediatric Drops in 50 mL (1 2/3 FL. OZ.) child-resistant bottles with accompanying calibrated dropper (Product Code: 15370-101-50).Rx Only

Storage

Store at controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from light, moisture and heat.SHAKE BEFORE USINGTAMPER EVIDENT: Do not use if seal is broken or missing.

* Please review the disclaimer below.

Previous Code
15370-100
Next Code
15370-102