NDC 15370-100 Quflora Pediatric Drops

NDC Product Code 15370-100

NDC 15370-100-50

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

This product is EXCLUDED from the official NDC directory because the listing certification is expired.

NDC Product Information

Quflora Pediatric Drops with NDC 15370-100 is a product labeled by Carwin Pharmaceutical Associates, Llc. The generic name of Quflora Pediatric Drops is . The product's dosage form is and is administered via form.

Labeler Name: Carwin Pharmaceutical Associates, Llc

Dosage Form: -

Product Type: 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.

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)

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
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)1,000 IU40%20%Vitamin C (as Ascorbic Acid)35 mg88%58%Vitamin D3 (as Cholecalciferol)400 IU100%100%Vitamin E (as D-Alpha-Tocopheryl Acetate)5 IU50%17%Thiamin (as Thiamine HCl, Vitamin B1)0.5 mg71%33%Riboflavin (Vitamin B2)0.6 mg75%35%Niacin (as Niacinamide)0.8 mg9%4%Vitamin B6 (as Pyridoxine HCl)0.4 mg57%20%Folate (as 65 mcg Quatrefolic® ((6S-5-methyltetrahydrofolic acid, glucosamine saltDaily Value (DV) not established, molar equivalent to 35 mcg of Folic Acid))35 mcg18%9%Vitamin B12 (as Cyanocobalamin)2 mcg67%33%Magnesium (as Magnesium Oxide)10 mg5%3%Copper (as Cupric Sulfate)1 mg100%50%Fluoride (as Sodium Fluoride)0.25 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-100-02Rev. 5/17

Indications And Usage

Quflora® 0.25 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® 0.25 mg/mL F* Pediatric Drops is a light brown, dye free, grape flavored liquid.

How Supplied

Quflora® 0.25 mg/mL F* Pediatric Drops in 50 mL (1 2/3 FL. OZ.) child-resistant bottles with accompanying calibrated dropper (Product Code: 15370-100-50).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.