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Quflora Pediatric Package Insert

Updated:
Facts
Status:
Prescription (Rx)
Strength:
1200 IU, 60 mg, 400 IU, 15 IU, 1.2 mg, 1.3 mg, 5 mg, 1.5 mg, 108 mcg, 100 mcg, 4 mcg, 15 mg, 1 mg, 0.25 mg, 1200 IU, 60 mg, 400 IU, 15 IU, 1.2 mg, 1.3 mg, 5 mg, 1.5 mg, 108 mcg, 100 mcg, 4 mcg, 15 mg, 1 mg, 0.5 mg, 1200 IU, 60 mg, 400 IU, 15 IU, 1.2 mg, 1.3 mg, 5 mg, 1.5 mg, 108 mcg, 100 mcg, 4 mcg, 15 mg, 1 mg, 1 mg
Drug class:
Active ingredients:
Similar drugs:

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

Prescribing information (package insert) - Quflora Pediatric

INDICATIONS AND USAGE

Quflora™ Pediatric Chewable Tablets with 0.5 mg Fluoride is a prescription dietary fluoride supplement providing twelve essential vitamins and minerals.

CONTRAINDICATIONS

Quflora™ Pediatric Chewable Tablets with 0.5 mg Fluoride should not be used by patients with a known history of hypersensitivity to any of the listed ingredients.

PRECAUTIONS

General

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. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed. Your healthcare practitioner can prescribe the correct dosage.

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.

ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported. Call your doctor for medical advice about side effects. You may report side effects or obtain product information 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. This product should be chewed and is not recommended for children under age 4.

DOSAGE AND ADMINISTRATION

One tablet daily or as prescribed by your healthcare practitioner. Each tablet contains 0.5 mg fluoride ion (F) from 1.1 mg sodium fluoride (NaF).

DESCRIPTION

Quflora™ Pediatric Chewable Tablets with 0.5 mg Fluoride is a yellow round tablet imprinted "104".

HOW SUPPLIED

Quflora™ Pediatric Chewable Tablets with 0.5 mg Fluoride available in child-resistant bottles of 30 (Product Code: 15370-104-30).

Rx Only

STORAGE

Store at controlled room temperature 20° C to 25° C (68° F to 77° F), excursions permitted between 15° C and 30° C (59° F and 86° F). Protect from light, moisture and excessive heat.

KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

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

Made in Canada

Rev. 4/16

About this document

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

Revision date stated in the text: April 2016

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

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 1200 IU, Ascorbic acid 60 mg, Cholecalciferol 400 IU, Alpha-tocopherol, DL- 15 IU, Thiamine hydrochloride 1.2 mg, Riboflavin 1.3 mg, Niacinamide 5 mg, Pyridoxine hydrochloride 1.5 mg, Levomefolic acid 108 mcg, Folic acid 100 mcg, Cyanocobalamin 4 mcg, Magnesium oxide 15 mg, Cupric sulfate 1 mg, Sodium fluoride
Dosage form Tablet, chewable
Route Oral
Marketing status listed in the 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
1200 IU, 60 mg, 400 IU, 15 IU, 1.2 mg, 1.3 mg, 5 mg, 1.5 mg, 108 mcg, 100 mcg, 4 mcg, 15 mg, 1 mg, 0.25 mg – 30 in 1 bottle NDC 15370-103-30
1200 IU, 60 mg, 400 IU, 15 IU, 1.2 mg, 1.3 mg, 5 mg, 1.5 mg, 108 mcg, 100 mcg, 4 mcg, 15 mg, 1 mg, 0.5 mg – 30 in 1 bottle NDC 15370-104-30
1200 IU, 60 mg, 400 IU, 15 IU, 1.2 mg, 1.3 mg, 5 mg, 1.5 mg, 108 mcg, 100 mcg, 4 mcg, 15 mg, 1 mg, 1 mg – 30 in 1 bottle NDC 15370-105-30

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.