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.
Folvita Complex
- Manufacturer
- Aletris Pharmaceuticals, LLC
- Effective date
- 2025-04-07
- Label type
- DIETARY SUPPLEMENT
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:51:34
Label at a glance#
ProductFolvita Complex
Active ingredientPYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN
Label structure12 sections
Contacts and useful links#
Label contents#
Full prescribing information#
HEALTH CLAIM SECTION
FOLVITA COMPLEXTM - Rx only [Dispensed by Prescription]
Prescription only Folic Acid Containing Dietary Supplement
STATEMENT OF IDENTITY SECTION
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 SECTION
Distributed by:
Aletris Pharmaceuticals, LLC,
Biloxi, MS 39532
(228) 207-8112
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2711570 | cyanocobalamin 400 MCG / folic acid 1000 MCG / pyridoxine HCl 10 MG Oral Tablet | PSN | 1 |
| 2711570 | folic acid 1 MG / vitamin B12 0.4 MG / vitamin B6 10 MG Oral Tablet | SCD | 1 |
| 2711570 | folate 1 MG / vitamin B12 0.4 MG / vitamin B6 10 MG Oral Tablet | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| b82b4008-22fd-05f5-6cc6-c0a6e81c65b8 | Product name | 2 | 20240805 |
| 91c62db0-0295-c81c-d10a-0856c259edd6 | Product name | 2 | 20200428 |
| d32bc2b8-0bb7-2216-87aa-24639646e202 | Product name | 3 | 20190619 |
| d206bb34-ea65-399d-70d9-834f22dc2c18 | Product name | 3 | 20170724 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 86001089077 | Folvita Complex | 30 in 1 BOTTLE | TABLET | 30 | 1 |
Products#
Every source-derived product name is available through these pages.
- Folvita Complex
- Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
- FOLIC ACID
- CYANOCOBALAMIN
- CALCIUM PHOSPHATE
- STEARIC ACID
- CROSCARMELLOSE SODIUM
- MAGNESIUM STEARATE
- SILICON DIOXIDE
- TRIACETIN
- POLYDEXTROSE
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- CARNAUBA WAX
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PYRIDOXINE HYDROCHLORIDE | 68Y4CF58BV | ACTIM |
| FOLIC ACID | 935E97BOY8 | ACTIB |
| CYANOCOBALAMIN | P6YC3EG204 | ACTIB |
| CALCIUM PHOSPHATE | 97Z1WI3NDX | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
| POLYDEXTROSE | VH2XOU12IE | IACT |
| HYDROXYPROPYL CELLULOSE, UNSPECIFIED | 9XZ8H6N6OH | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pyridoxine Hydrochloride | PYRIDOXINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | a56d11c0-b033-4201-85ff-fc710506481a | 2024-10-15 | Warnings, Adverse reactions | PYRIDOXINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.