Multi-Vitamin Drops with Fluoride and Iron

Multi-Vitamin Drops with Fluoride and Iron 0_25 mg

Approved

Approval ID

d5609742-e456-4409-bca9-706b0ea90d35

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 12, 2023

Manufacturers

FDA

Method Pharmaceuticals, LLC

DUNS: 060216698

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, Ferrous sulfate and SODIUM FLUORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code58657-327

Product Classification

Generic Name

VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, Ferrous sulfate and SODIUM FLUORIDE

Product Specifications

Route of AdministrationORAL

Effective DateDecember 12, 2023

FDA Product Classification

INGREDIENTS (18)

FERROUS SULFATEActive

Quantity: 10 mg in 1 mL

Code: 39R4TAN1VT

Classification: ACTIM

SODIUM FLUORIDEActive

Quantity: 0.25 mg in 1 mL

Code: 8ZYQ1474W7

Classification: ACTIM

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

GLYCERINInactive

Code: PDC6A3C0OX

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

POTASSIUM SORBATEInactive

Code: 1VPU26JZZ4

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

SORBITOLInactive

Code: 506T60A25R

Classification: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4

Classification: IACT

CHOLECALCIFEROLActive

Quantity: 400 [iU] in 1 mL

Code: 1C6V77QF41

Classification: ACTIB

ASCORBIC ACIDActive

Quantity: 35 mg in 1 mL

Code: PQ6CK8PD0R

Classification: ACTIB

VITAMIN A PALMITATEActive

Quantity: 1500 [iU] in 1 mL

Code: 1D1K0N0VVC

Classification: ACTIM

THIAMINE HYDROCHLORIDEActive

Quantity: 0.5 mg in 1 mL

Code: M572600E5P

Classification: ACTIR

RIBOFLAVIN 5'-PHOSPHATE SODIUMActive

Quantity: 0.6 mg in 1 mL

Code: 20RD1DZH99

Classification: ACTIM

NIACINAMIDEActive

Quantity: 8 mg in 1 mL

Code: 25X51I8RD4

Classification: ACTIB

PYRIDOXINE HYDROCHLORIDEActive

Quantity: 0.4 mg in 1 mL

Code: 68Y4CF58BV

Classification: ACTIB

.ALPHA.-TOCOPHEROL SUCCINATE, D-Active

Quantity: 5 [iU] in 1 mL

Code: LU4B53JYVE

Classification: ACTIB

Drug Labeling Information

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/9/2017

DOSAGE AND ADMINISTRATION:

See following chart. May be dropped directly into the mouth with dropper; or mixed with cereal, fruit juice or other food.

FluorideIon**LevelinDrinking Water**(ppm)*****
Age	<0.3****ppm	0.3****-0.6ppm	>0.6****ppm
Birth - 6 months	None	None	None
6 mos - 3 years	0.25 mg (1 mL) / day †	None	None
3 - 6 years	0.50 mg (2 mL) / day	0.25 mg (1 mL) / day	None

1.0 ppm = 1 mg/liter

† 2.2 mg sodium fluoride contains 1 mg fluoride ion.

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Multi-Vitamin Drops with Fluoride and Iron

Products 1

VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, Ferrous sulfate and SODIUM FLUORIDE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Drug Labeling Information

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION:

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