MedPath
FDA Product

Quflora Pediatric

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Quflora Pediatric

15370-105

Regulatory Information

15370-105

January 10, 2024

Quflora™ Pediatric Chewable Tablets

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

079217215

Active Ingredients

VITAMIN A ACETATE

Quantity: 1200 [iU] in 1 1

Code: 3LE3D9D6OY

Class Code: ACTIM

CHOLECALCIFEROL

Quantity: 400 [iU] in 1 1

Code: 1C6V77QF41

Class Code: ACTIB

ASCORBIC ACID

Quantity: 60 mg in 1 1

Code: PQ6CK8PD0R

Class Code: ACTIB

RIBOFLAVIN

Quantity: 1.3 mg in 1 1

Code: TLM2976OFR

Class Code: ACTIB

THIAMINE HYDROCHLORIDE

Quantity: 1.2 mg in 1 1

Code: M572600E5P

Class Code: ACTIR

NIACINAMIDE

Quantity: 5 mg in 1 1

Code: 25X51I8RD4

Class Code: ACTIB

CUPRIC SULFATE

Quantity: 1 mg in 1 1

Code: LRX7AJ16DT

Class Code: ACTIM

LEVOMEFOLIC ACID

Quantity: 108 ug in 1 1

Code: 8S95DH25XC

Class Code: ACTIB

CYANOCOBALAMIN

Quantity: 4 ug in 1 1

Code: P6YC3EG204

Class Code: ACTIB

PYRIDOXINE HYDROCHLORIDE

Quantity: 1.5 mg in 1 1

Code: 68Y4CF58BV

Class Code: ACTIB

FOLIC ACID

Quantity: 100 ug in 1 1

Code: 935E97BOY8

Class Code: ACTIB

MAGNESIUM OXIDE

Quantity: 15 mg in 1 1

Code: 3A3U0GI71G

Class Code: ACTIB

SODIUM FLUORIDE

Quantity: 1 mg in 1 1

Code: 8ZYQ1474W7

Class Code: ACTIM

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SUCRALOSE

Code: 96K6UQ3ZD4

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

GRAPE

Code: 6X543N684K

Class Code: IACT

CITRIC ACID MONOHYDRATE

Code: 2968PHW8QP

Class Code: IACT

.ALPHA.-TOCOPHEROL, DL-

Quantity: 15 [iU] in 1 1

Code: 7QWA1RIO01

Class Code: ACTIB

Active Moieties

.ALPHA.-TOCOPHEROL, DL-

Code: 7QWA1RIO01

VITAMIN A

Code: 81G40H8B0T

CHOLECALCIFEROL

Code: 1C6V77QF41

ASCORBIC ACID

Code: PQ6CK8PD0R

PYRIDOXINE

Code: KV2JZ1BI6Z

THIAMINE ION

Code: 4ABT0J945J

RIBOFLAVIN

Code: TLM2976OFR

FOLIC ACID

Code: 935E97BOY8

CYANOCOBALAMIN

Code: P6YC3EG204

MAGNESIUM CATION

Code: T6V3LHY838

NIACINAMIDE

Code: 25X51I8RD4

LEVOMEFOLIC ACID

Code: 8S95DH25XC

FLUORIDE ION

Code: Q80VPU408O

CUPRIC CATION

Code: 8CBV67279L

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