DailyMed - FOLETRA- vitamin capsule

NHRIC Code(s): 72835-440-01
Packager: V2 Pharma LLC

Category: DIETARY SUPPLEMENT
DEA Schedule: None
Marketing Status: Dietary Supplement

Drug Label Information

Updated May 12, 2025

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Supplement Facts

Foletra Capsules - Dietary Supplement - Supplement Facts - Serving Size: 1 Capsule - Servings Per Bottle: 30 - Ingredients Amount Per Serving%DV - Vitamin C (as Ascorbic Acid) 90 ...

Description:
Foletra is an orally administered vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is needed. Foletra ...

Foletra is an orally administered vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is needed. Foletra provides significant amounts of Vitamins B6, B12, C, D3, E, riboflavin, niacinamide, and thiamine mononitrate to supplement the diet.
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Contraindications
Foletra is contraindicated in patients with a known hypersensitivity to any of the contained ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a ...

Foletra is contraindicated in patients with a known hypersensitivity to any of the contained ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a licensed medical practitioner.

Precaution

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Foletra should only be used under the direction and supervision of a licensed medical practitioner.

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WARNINGS
KEEP FOLETRA OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a licensed medical practitioner or poison control center immediately. For use under the supervision of a licensed ...

KEEP FOLETRA OUT OF THE REACH OF CHILDREN.
In case of accidental overdose, call a licensed medical practitioner or poison control center immediately.
For use under the supervision of a licensed medical practitioner.

Consult your physician prior to using Foletra if you are pregnant, nursing, taking medication, or have a medical condition.
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Doseage and Administration
Suggested use is 1 capsule taken orally once daily or as prescribed by a licensed medical practitioner.

Suggested use is 1 capsule taken orally once daily or as prescribed by a licensed medical practitioner.
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Storage and Handling
Store at room temperature. Avoid excessive heat, light, and moisture. Statements - These statements have not been evaluated by the Food and Drug Administration. This product is not intended to ...

Store at room temperature. Avoid excessive heat, light, and moisture.

Statements

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

How Supplied

Foletra capsules are available in 30 count bottles. 72835-440-01

Manufactured for:
V2 Pharma, LLC
103 W Main Street
Hudson, MI 49247

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Foletra Label

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Ingredients	Amount Per Serving	%DV
Vitamin C (as Ascorbic Acid)	90 mg	100%
Vitamin D3 (as Cholecalciferol)	20 mcg	100%
Vitamin E (as d-Alpha Tocopheryl Succinate)	10.05 mg	67%
Thiamine (as Thiamine Mononitrate)	1.4 mg	116%
Riboflavin (as Riboflavin 5 Phosphate)	1.6 mg	123%
Niacin (as Niacinamide)	16.3 mg	101%
Vitamin B-6 (as Pyridoxine HCl)	2.5 mg	147%
Folate (from 1000 mcg Folic Acid)	1700 mcg DFE	425%
Vitamin B-12 (as Methylcobalamin)	10 mcg	416%

INGREDIENTS AND APPEARANCE

Product Information

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
shape
size (solid drugs)	16 mm
scoring	1
color

Establishment
Name	Address	ID/FEI	Business Operations
V2 Pharma LLC		102457346	label(72835-440) , manufacture(72835-440)

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Published Date (What is this?)	Version	Files
May 19, 2025	4 (current)	download
Mar 21, 2025	3	download
Mar 13, 2025	2	download
Mar 10, 2025	1	download

Label: FOLETRA- vitamin capsule

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Label: FOLETRA- vitamin capsule

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FOLETRA- vitamin capsule

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FOLETRA- vitamin capsule

FOLETRA- vitamin capsule

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FOLETRA- vitamin capsule

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.