Quflora Pediatric Drops
FDA Label NDC 15370-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Carwin Pharmaceutical Associates, Llc for the product Quflora Pediatric Drops (NDC 15370-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, indications and usage, contraindications, general, folic acid, other information, warnings, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Supplement Facts
Serving Size: 1 mL
Servings Per Container: 50
Amount 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 age
Vitamin 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 salt

Daily 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 mg

Other 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# 1181972-37-1

Manufactured for:
Carwin Pharmaceutical Associates, LLC
Hazlet, NJ 07730

CAR-101-02
Rev. 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 ppm
Birth-6 monthsNoneNoneNone
6 months-3 years0.25 mg/day

2.2 mg sodium fluoride contains 1 mg fluoride ion

NoneNone
3-6 years0.50 mg/day0.25 mg/dayNone
6-16 years1.0 mg/day0.50 mg/dayNone

Dietary 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 USING

TAMPER EVIDENT: Do not use if seal is broken or missing.

Principal Display Panel - 50 Ml Bottle Carton

15370-101-50

QUfLORA™
PEDIATRIC
Liquid Drops

Dietary Supplement
0.5 mg/mL Fluoride

Each dropperful (1 mL) contains:
1.1 mg sodium fluoride, USP

Rx Only • Grape Flavor

50 mL
(1⅔ fl oz.)

carwin
PHARMACEUTICAL ASSOCIATES

Quatrefolic®

Principal Display Panel (50 mL Bottle Carton)

Principal Display Panel (50 mL Bottle Carton)

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