Quflora Pediatric (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — 1 mg Tablet Bottle Label

15370-105-30

QUf 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 -- 1 mg Tablet Bottle Label
(click image for full-size original)
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
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15370-103
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A ACETATE (VITAMIN A) VITAMIN A 1200 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 15 [iU]
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE 1.2 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 5 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 1.5 mg
LEVOMEFOLIC ACID (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 108 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 100 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4 ug
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 15 mg
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 1 mg
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.25 mg
Inactive Ingredients
Ingredient Name Strength
GRAPE
CITRIC ACID MONOHYDRATE
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SUCRALOSE
SUCROSE
STEARIC ACID
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor GRAPE Imprint Code 103
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15370-103-30 30 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/06/2014
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
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15370-104
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A ACETATE (VITAMIN A) VITAMIN A 1200 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 15 [iU]
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE 1.2 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 5 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 1.5 mg
LEVOMEFOLIC ACID (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 108 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 100 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4 ug
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 15 mg
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 1 mg
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.5 mg
Inactive Ingredients
Ingredient Name Strength
GRAPE
CITRIC ACID MONOHYDRATE
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SUCRALOSE
SUCROSE
STEARIC ACID
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor GRAPE Imprint Code 104
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15370-104-30 30 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/06/2014
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
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15370-105
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A ACETATE (VITAMIN A) VITAMIN A 1200 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 15 [iU]
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE 1.2 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 5 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 1.5 mg
LEVOMEFOLIC ACID (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 108 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 100 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4 ug
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 15 mg
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 1 mg
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1 mg
Inactive Ingredients
Ingredient Name Strength
GRAPE
CITRIC ACID MONOHYDRATE
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SUCRALOSE
SUCROSE
STEARIC ACID
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor GRAPE Imprint Code 105
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15370-105-30 30 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/06/2014
Labeler — CarWin Pharmaceutical Associates, LLC (079217215)

Revised: 01/2024 CarWin Pharmaceutical Associates, LLC

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