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Quflora FE Pediatric Drops Package Insert

Updated:
Facts
Status:
Prescription (Rx) Boxed warning
Strength:
1500 IU/mL, 36 mg/mL, 400 IU/mL, 5 IU/mL, 0.5 mg/mL, 0.6 mg/mL, 4 mg/mL, 1 mg/mL, 0.4 mg/mL, 3 mcg/mL, 37.5 mcg/mL, 2 mcg/mL, 9.5 mg/mL, 0.25 mg/mL
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Quflora FE Pediatric Drops

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 IU60%30%
Vitamin C (as Ascorbic Acid)36 mg90%60%
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)4 mg45%20%
Pantothenic Acid1 mg20%10%
Vitamin B6 (as Pyridoxine HCl)0.4 mg57%20%
Biotin3 mcg2%1%
Folate (as 69 mcg Quatrefolic® ((6S)-5 Methyltetrahydrofolic acid, glucosamine salt, molar equivalent to 37.5 mcg of Folic Acid))37.5 mcg20%10%
Vitamin B12 (as Cyanocobalamin)2 mcg67%33%
Iron (as Ferrous Sulfate)9.5 mg95%53%
Fluoride (as Sodium Fluoride)0.25 mgDaily Value not established

Other Ingredients: Purified Water, Citric Acid, Glycerin, Grape Flavor, Sorbitol, Propylene Glycol, Sucralose, Sodium Benzoate.

INDICATIONS AND USAGE

Quflora® FE Pediatric Liquid Drops is a prescription dietary supplement providing essential vitamins, iron 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.

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.

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.

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.

Other information

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

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)

AgeLess than 0.3ppm0.3-0.6 ppmGreater than 0.6 ppm
Birth-6 monthsNoneNoneNone
6 months-3 years0.25 mg/day2.2 mg sodium fluoride contains 1 mg fluoride ionNoneNone
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® FE Pediatric Liquid Drops is a yellow, dye free, grape flavored liquid.

HOW SUPPLIED

Quflora® FE Pediatric Liquid Drops in a 50 mL (1 ⅔ 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 20°C to 25°C (68°F to 77°F) away from heat and sunlight.

SHAKE WELL BEFORE USING

TAMPER EVIDENT

Do not use if seal is broken or missing.

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

www.carwinpharma.com

Rev. 3/17

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

Revision date stated in the text: March 2017

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Quflora FE Pediatric Drops

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Vitamin A, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Vitamin A palmitate 1500 IU/mL, Ascorbic acid 36 mg/mL, Cholecalciferol 400 IU/mL, Alpha-tocopherol acetate, D- 5 IU/mL, Thiamine hydrochloride 0.5 mg/mL, Riboflavin 0.6 mg/mL, Niacinamide 4 mg/mL, Pantothenic acid 1 mg/mL, Pyridoxine hydrochloride 0.4 mg/mL, Biotin 3 mcg/mL, Levomefolate glucosamine 37.5 mcg/mL, Cyanocobalamin 2 mcg/mL, Ferrous sulfate 9.5 mg/mL, Sodium fluoride 0.25 mg/mL
Dosage form Liquid
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) Carwin Pharmaceutical Associates, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
1500 IU/mL, 36 mg/mL, 400 IU/mL, 5 IU/mL, 0.5 mg/mL, 0.6 mg/mL, 4 mg/mL, 1 mg/mL, 0.4 mg/mL, 3 mcg/mL, 37.5 mcg/mL, 2 mcg/mL, 9.5 mg/mL, 0.25 mg/mL – 50 ml in 1 bottle, dropper / 1 in 1 carton NDC 15370-102-50

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.