FDA Label for Quflora Pediatric
View Indications, Usage & Precautions
- OTHER
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
- GENERAL
- FOLIC ACID
- ADVERSE REACTIONS
- WARNINGS
- DOSAGE AND ADMINISTRATION
- DESCRIPTION
- HOW SUPPLIED
- STORAGE
- TAMPER EVIDENT
- PRINCIPAL DISPLAY PANEL - 0.25 MG TABLET BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 0.5 MG TABLET BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 1 MG TABLET BOTTLE LABEL
Quflora Pediatric Product Label
The following document was submitted to the FDA by the labeler of this product Carwin Pharmaceutical Associates, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Tablet Servings per Container: 30 | ||
| Amount per Serving | % Daily Value %Daily Value for Adults and Children 4 or more years of age | |
| Vitamin A (as Acetate) | 1,200 IU | 24% |
| Vitamin C (as Ascorbic Acid) | 60 mg | 100% |
| Vitamin D3 (as Cholecalciferol) | 400 IU | 100% |
| Vitamin E (as DL-Alpha Tocopheryl Acetate) | 15 IU | 50% |
| Thiamin (as Thiamine HCl, Vitamin B1) | 1.2 mg | 80% |
| Riboflavin (Vitamin B2) | 1.3 mg | 76% |
| Niacin (as Niacinamide) | 5 mg | 25% |
| Vitamin B6 (as Pyridoxine HCl) | 1.5 mg | 75% |
| Folate (as 200 mcg Quatrefolic® ((6S-5-methyltetrahydrofolic acid, glucosamine salt, molar equivalent to 108 mcg of Folic Acid), and 100 mcg of folic acid) | 208 mcg | 52% |
| Vitamin B12 (as Cyanocobalamin) | 4 mcg | 67% |
| Magnesium (as Magnesium Oxide) | 15 mg | 4% |
| Copper (as Cupric Sulfate) | 1 mg | 50% |
| Fluoride (as Sodium Fluoride) | 0.5 mg | Daily Value not established |
Other Ingredients: Citric acid, fumed silica, magnesium stearate, microcrystalline cellulose, natural grape flavor, silicon dioxide, stearic acid, sucralose, sucrose and xylitol.
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
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.
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.
Principal Display Panel - 0.25 Mg Tablet Bottle Label
15370-103-30
QUfLORA™
PEDIATRIC
Chewable Tablets
Multivitamin with
0.25 mg Fluoride
Each chewable tablet contains:
0.55 mg sodium fluoride, USP
Rx Only • Grape Flavor
30 Tablets
carwin
PHARMACEUTICAL ASSOCIATES
Principal Display Panel - 0.5 Mg Tablet Bottle Label
15370-104-30
QUfLORA™
PEDIATRIC
Chewable Tablets
Multivitamin with
0.5 mg Fluoride
Each chewable tablet contains:
1.1 mg sodium fluoride, USP
Rx Only • Grape Flavor
30 Tablets
carwin
PHARMACEUTICAL ASSOCIATES
Principal Display Panel - 1 Mg Tablet Bottle Label
15370-105-30
QUfLORA™
PEDIATRIC
Chewable Tablets
Multivitamin with
1 mg Fluoride
Each chewable tablet contains:
2.2 mg sodium fluoride, USP
Rx Only • Grape Flavor
30 Tablets
carwin
PHARMACEUTICAL ASSOCIATES
* Please review the disclaimer below.