MedPath

SiderAL Folic

SiderAL FolicPlus Folic Acid adn Vitamins

Approved
Approval ID

c3df42ec-8409-48f3-993d-afce1d601021

Product Type

DIETARY SUPPLEMENT

Effective Date

Aug 14, 2025

Manufacturers
FDA

PharmaNutra Usa Corp.

DUNS: 119066016

Products 1

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

Iron

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84797-002
Product Classification
G
Generic Name
Iron
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2025
FDA Product Classification

INGREDIENTS (11)

SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
IRONActive
Quantity: 30 mg in 1 mg
Code: E1UOL152H7
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 70 mg in 1 mg
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 0.01 mg in 1 mg
Code: 1C6V77QF41
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 1 mg in 1 mg
Code: 68Y4CF58BV
Classification: ACTIM
FOLIC ACIDActive
Quantity: .4 mg in 1 mg
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 0.00175 mg in 1 mg
Code: P6YC3EG204
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/14/2025

Sideral Folic Label

Sideral Folic Stick

Sideral Folic Insert

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/14/2025

**Suggested use:**Advised dosage is 1 stick a day directly dissolved in the mouth.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/14/2025

**Warnings:**Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children.In case of accidental overdose, call a doctor or poison control center immediately.

HEALTH CLAIM SECTION

LOINC: 69719-3Updated: 8/14/2025

Sideal Folic is a dietary supplement with Sucrosomial Iron and vitamins, useful to cover dietary deficiencies or a increased demand for said nutrients. Sucrosomial Iron can pass the gastric environment intact to be directly absorbed in the intestine, thus avoiding any gastric disorder.

STATEMENT OF IDENTITY SECTION

LOINC: 69718-5Updated: 8/14/2025

Supplement Facts
Serving Size: 1 Stick
Serving per container: 30 sticks
Amount per Serving % Daily Value

Calories 5

Total Carbohydrate 1 g <1%

Vitamin C (as Ascorbic Acid) 70 mg 78%

Vitamin D (as Cholecalciferol) 10 mcg 50%

Vitamin B6 (as Pyridoxine Hydrochloride) 1 mg 59%

Folic Acid 400 mcg 100%

Vitamin B12 (as Cyanochobalamin) 1.75 mcg 73%

Iron (as Iron Pyrophosphate) 30 mg 167%

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 8/14/2025

**Caution:**Do not exceed the recommended daily dose. Consult your healthcare practitioner before using this product, especially if you are pregnant, nursing, anticipate surgery, take medication on a regular basis or are otherwise under medical supervision. Dietary supplement must not be considered a substitute for a varied balanced diet and a healthy lifestyle. The product contains polyalcohols; excessive consumption might have a laxative effect. For adult use only.Keep out of the sight and reach of children.

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