FOLVITA COMPLEX- pyridoxine hydrochloride, folic acid, cyanocobalamin tablet

Folvita Complex by

Drug Labeling and Warnings

Folvita Complex by is a Other medication manufactured, distributed, or labeled by Aletris Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM

FOLVITA COMPLEXTM - Rx only [Dispensed by Prescription]
Prescription only Folic Acid Containing Dietary Supplement

STATEMENT OF IDENTITY

FOLVITA COMPLEXTM
ACTIVE INGREDIENTS: Each tablet contains pyridoxine hydrochloride, folic acid, cyanocobalamin.

Serving Size: 1 Tablet  Serving per Container: 30
Each Tablet Contains:		% Daily Value
Vitamin B-6 (as Pyridoxine HCl)	10 mg	588%
Folate	1,667 mcg DFE (from 1,000 mcg Folic Acid)	417%
Vitamin B-12  (as Cyanocobalamin)	400 mcg	16,667%

OTHER INGREDIENTS: Calcium Phosphate, Modified Cellulose, Stearic Acid, Croscarmellose Sodium, Magnesium Stearate, Silicon Dioxide, Triacetin, Polydextrose, Wax.

DESCRIPTION

FOLVITA COMPLEXTM is an orally administered prescription only dietary supplement. 

INDICATIONS

FOLVITA COMPLEXTM tablets are indicated for nutritional support and folic acid supplementation.

CONTRADINDICATIONS

FOLVITA COMPLEXTM is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING

Keep this and all medications out of the reach of children. 

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact: Aletris Pharmaceuticals, LLC at 228-207-8112.

DOSAGE AND ADMINISTRATION

One tablet daily with food or as directed by a physician. 

Before, during and/or after pregnancy, one tablet daily with food or as directed by a physician.

PRECAUTION:

Folic acid in doses as low as 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive.

STORAGE

Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Avoid excessive heat, light
and moisture.

HEALTH CLAIM

Distributed by:
Aletris Pharmaceuticals, LLC,
Biloxi, MS 39532
(228) 207-8112

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOLVITA COMPLEX 
pyridoxine hydrochloride, folic acid, cyanocobalamin tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	86001089077
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1667 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	400 ug

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIACETIN (UNII: XHX3C3X673)
POLYDEXTROSE (UNII: VH2XOU12IE)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	86001089077	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		04/07/2025

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
scoring	1
size (solid drugs)	19 mm

Labeler - Aletris Pharmaceuticals, LLC (118956541)

Establishment
Name	Address	ID/FEI	Business Operations
Aletris Pharmaceuticals, LLC		118956541