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Quflora Pediatric Drops Package Insert

Updated:
Facts
Status:
Prescription (Rx)
Strength:
1000 IU/mL, 35 mg/mL, 400 IU/mL, 5 IU/mL, 0.5 mg/mL, 0.6 mg/mL, 0.8 mg/mL, 0.4 mg/mL, 35 mcg/mL, 2 mcg/mL, 10 mg/mL, 1 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 Pediatric Drops

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.

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.

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/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® 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 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

CAR-100-02

Rev. 5/17

About this document

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

Revision date stated in the text: May 2017

Found a mistake? Write to us via the contact page.

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

Drug information for Quflora Pediatric Drops

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Calculi Dissolution Agent, Folate Analog, Osmotic Laxative, Vitamin A, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Vitamin A acetate 1000 IU/mL, Ascorbic acid 35 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 0.8 mg/mL, Pyridoxine hydrochloride 0.4 mg/mL, Levomefolic acid 35 mcg/mL, Cyanocobalamin 2 mcg/mL, Magnesium oxide 10 mg/mL, Cupric sulfate 1 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
1000 IU/mL, 35 mg/mL, 400 IU/mL, 5 IU/mL, 0.5 mg/mL, 0.6 mg/mL, 0.8 mg/mL, 0.4 mg/mL, 35 mcg/mL, 2 mcg/mL, 10 mg/mL, 1 mg/mL, 0.25 mg/mL – 50 ml in 1 bottle, dropper / 1 in 1 carton NDC 15370-100-50

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.