Quflora Pediatric

VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE · Tablet, Chewable · Oral

Prescription (Rx) Calculi Dissolution Agent Folate Analog Osmotic Laxative

Uses

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

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).

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.

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.

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.

Side effects

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.

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.

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.

Label text from the FDA structured product label by CarWin Pharmaceutical Associates, LLC (revised Jan 10, 2024). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Quflora Pediatric NDC products (3)

NDCStrength & formLabelerType
15370-103Vitamin A Acetate 1200 [iU]/1; Ascorbic Acid 60 mg/1; Cholecalciferol 400 [iU]/1; .alpha.-tocopherol, Dl- 15 [iU]/1;…
Tablet, Chewable
CarWin Pharmaceutical Associates, LLCUNAPPROVED DRUG OTHER
15370-104Vitamin A Acetate 1200 [iU]/1; Ascorbic Acid 60 mg/1; Cholecalciferol 400 [iU]/1; .alpha.-tocopherol, Dl- 15 [iU]/1;…
Tablet, Chewable
CarWin Pharmaceutical Associates, LLCUNAPPROVED DRUG OTHER
15370-105Vitamin A Acetate 1200 [iU]/1; Ascorbic Acid 60 mg/1; Cholecalciferol 400 [iU]/1; .alpha.-tocopherol, Dl- 15 [iU]/1;…
Tablet, Chewable
CarWin Pharmaceutical Associates, LLCUNAPPROVED DRUG OTHER

Frequently asked questions

What is Quflora Pediatric used for?

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

What are the side effects of Quflora Pediatric?

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. See the full label for the complete list.

Who makes Quflora Pediatric?

Quflora Pediatric is listed by 1 labeler in the FDA NDC directory, including CarWin Pharmaceutical Associates, LLC.