Search by Drug Name or NDC

NDC 15370-0101-50 Quflora Pediatric Drops 12; 45; 400; 1; 3; 81; 12; 2; 1; 1; .5; 1; 1100 [iU]/mL; mg/mL; [iU]/mL; mg/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Details

Quflora Pediatric Drops 12; 45; 400; 1; 3; 81; 12; 2; 1; 1; .5; 1; 1100 [iU]/mL; mg/mL; [iU]/mL; mg/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL

Quflora Pediatric Drops is a ORAL LIQUID in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by CarWin Pharmaceutical Associates, LLC. The primary component is .ALPHA.-TOCOPHEROL ACETATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; LEVOMEFOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATE.

Product Information

NDC	15370-0101
Product ID	15370-101_1db30c36-f26f-48b2-bcf8-060aede3258f
Associated GPIs	78441000002010
GCN Sequence Number	072631
GCN Sequence Number Description	pedi multivit 84 with fluoride DROPS 0.5 MG/ML ORAL
HIC3	C6H
HIC3 Description	PEDIATRIC VITAMIN PREPARATIONS
GCN	36903
HICL Sequence Number	041314
HICL Sequence Number Description	PEDIATRIC MULTIVITAMIN NO.84 WITH SODIUM FLUORIDE
Brand/Generic	Brand
Proprietary Name	Quflora Pediatric Drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	12; 45; 400; 1; 3; 81; 12; 2; 1; 1; .5; 1; 1100
Active Ingredient Units	[iU]/mL; mg/mL; [iU]/mL; mg/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL
Substance Name	.ALPHA.-TOCOPHEROL ACETATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; LEVOMEFOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATE
Labeler Name	CarWin Pharmaceutical Associates, LLC
Pharmaceutical Class	Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 15370-0101-50 (15370010150)

Pricing Information	N/A
NDC Package Code	15370-101-50
Billing NDC	15370010150
Package	1 BOTTLE, DROPPER in 1 CARTON (15370-101-50) / 50 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2014-07-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 539225d3-7457-4bbe-a79a-4c10dba44e81 Details

SPL UNCLASSIFIED SECTION

Supplement Facts Serving Size: 1 mL Servings Per Container: 50
Amount Per 1 mL		% Daily Value Children 6 months to under 4 years of age	% Daily Value for Adults and Children 4 or more years of age
* Daily Value (DV) not established
Vitamin A (as Acetate)	1,100 IU	44%	22%
Vitamin C (as Ascorbic Acid)	45 mg	113%	75%
Vitamin D3 (as Cholecalciferol)	400 IU	100%	100%
Vitamin E (as D-Alpha-Tocopheryl Acetate)	12 IU	120%	40%
Thiamin (as Thiamine HCl, Vitamin B1)	1 mg	143%	67%
Riboflavin (Vitamin B2)	1 mg	125%	59%
Niacin (as Niacinamide)	2 mg	22%	10%
Vitamin B6 (as Pyridoxine HCl)	1 mg	143%	50%
Folate (as 150 mcg Quatrefolic® ((6S)-5-methyltetrahydrofolic acid, glucosamine salt*, molar equivalent to 81 mcg of Folic Acid))	81 mcg	41%	20%
Vitamin B12 (as Cyanocobalamin)	3 mcg	100%	50%
Magnesium (as Magnesium Oxide)	12 mg	6%	3%
Copper (as Cupric Sulfate)	1 mg	100%	50%
Fluoride (as Sodium Fluoride)	0.5 mg	*	*

Other Ingredients: Purified Water, Carrageenan, Sorbitol, Propylene Glycol, Glycerin, Grape Flavor, Potassium Sorbate, Sodium Benzoate, Citric Acid and Sucralose.

INDICATIONS AND USAGE

Quflora® 0.5 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)*
Age	Less than 0.3ppm	0.3-0.6 ppm	Greater than 0.6 ppm
* 1.0 part per million (ppm) = 1 milligram/liter (mg/L) † 2.2 mg sodium fluoride contains 1 mg fluoride ion
Birth-6 months	None	None	None
6 months-3 years	0.25 mg/day†	None	None
3-6 years	0.50 mg/day†	0.25 mg/day	None
6-16 years	1.0 mg/day	0.50 mg/day	None

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® 0.5 mg/mL F* Pediatric Drops is a light brown, dye free, grape flavored liquid.

HOW SUPPLIED

Quflora® 0.5 mg/mL F* Pediatric Drops in 50 mL (1 2/3 FL. OZ.) child-resistant bottles with accompanying calibrated dropper (Product Code: 15370-101-50).

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.

SPL UNCLASSIFIED SECTION

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-101-02

Rev. 5/17

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

15370-101-50

QUfLORA™

PEDIATRIC

Liquid Drops

Dietary Supplement

0.5 mg/mL Fluoride

Each dropperful (1 mL) contains:

1.1 mg sodium fluoride, USP

Rx Only • Grape Flavor

50 mL

(1⅔ fl oz.)

carwin

PHARMACEUTICAL ASSOCIATES

Quatrefolic®

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

INGREDIENTS AND APPEARANCE

QUFLORA PEDIATRIC DROPS

vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, levomefolic acid, cyanocobalamin, magnesium oxide, cupric sulfate, and sodium fluoride liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:15370-101
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	1100 [iU] in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	45 mg in 1 mL
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU] in 1 mL
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	12 [iU] in 1 mL
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1 mg in 1 mL
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1 mg in 1 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	2 mg in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	1 mg in 1 mL
LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLIC ACID	81 ug in 1 mL
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	3 ug in 1 mL
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM OXIDE	12 mg in 1 mL
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	1 mg in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARRAGEENAN (UNII: 5C69YCD2YJ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GRAPE (UNII: 6X543N684K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:15370-101-50	1 in 1 CARTON	07/15/2014
1		50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		07/15/2014

Labeler - CarWin Pharmaceutical Associates, LLC (079217215)

Revised: 8/2017

Document Id: 1db30c36-f26f-48b2-bcf8-060aede3258f

Set id: 539225d3-7457-4bbe-a79a-4c10dba44e81

Version: 2

Effective Time: 20170803

Search by Drug Name or NDC

NDC 15370-0101-50 Quflora Pediatric Drops 12; 45; 400; 1; 3; 81; 12; 2; 1; 1; .5; 1; 1100 [iU]/mL; mg/mL; [iU]/mL; mg/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Details

Quflora Pediatric Drops 12; 45; 400; 1; 3; 81; 12; 2; 1; 1; .5; 1; 1100 [iU]/mL; mg/mL; [iU]/mL; mg/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL

Product Information

Package

Package Images

NDC 15370-0101-50 (15370010150)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 539225d3-7457-4bbe-a79a-4c10dba44e81 Details

SPL UNCLASSIFIED SECTION

INDICATIONS AND USAGE

CONTRAINDICATIONS

PRECAUTIONS

General

Folic Acid

Other information

WARNINGS

DOSAGE AND ADMINISTRATION

DESCRIPTION

HOW SUPPLIED

STORAGE

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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