quflora™ pediatric chewable tablets

Drug Facts

Composition & Product

Active Ingredients

vitamin a (1200 [iU]) ascorbic acid (60 mg) cholecalciferol (400 [iU]) .alpha.-tocopherol, dl- (15 [iU]) riboflavin (1.2 mg) niacinamide (1.3 mg) pyridoxine (5 mg) levomefolic acid (1.5 mg) folic acid (108 ug) cyanocobalamin (100 ug) magnesium cation (4 ug) cupric cation (15 mg) fluoride ion (1 mg)

Inactive Ingredients

grape citric acid monohydrate silicon dioxide magnesium stearate microcrystalline cellulose sucralose sucrose stearic acid

Identifiers & Packaging

Pill Appearance

Imprint: 105 Shape: round Color: white Size: 12 mm Score: 1

Marketing Status

unapproved drug other active Since 2014-01-06

Medication Information

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.

Indications and Usage

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.

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.

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

Description

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

Section 42229-5

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

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.

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.

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.

Tamper Evident

Do not use if seal is broken or missing.

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

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 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

Structured Label Content

Warnings (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.

Indications and Usage (INDICATIONS AND USAGE)

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

Dosage and Administration (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 (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.

Adverse Reactions (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.

How Supplied (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

Description (DESCRIPTION)

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

Section 42229-5 (42229-5)

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

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.

Storage (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.

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.

Tamper Evident (TAMPER EVIDENT)

Do not use if seal is broken or missing.

Principal Display Panel 1 Mg Tablet Bottle Label (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

Principal Display Panel 0.5 Mg Tablet Bottle Label (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 0.25 Mg Tablet Bottle Label (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

Advanced Ingredient Data

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{"42229-5": "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", "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.", "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.", "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.", "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.", "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", "TAMPER EVIDENT": "Do not use if seal is broken or missing.", "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.", "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.", "INDICATIONS AND USAGE": "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).", "PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label": "15370-105-30 QU f LORA™ 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", "PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label": "15370-104-30 QU f LORA™ 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 - 0.25 mg Tablet Bottle Label": "15370-103-30 QU f LORA™ 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"}

quflora™ pediatric chewable tablets

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