Virt-Gard tablets are indicated for nutritional support and folic acid supplementation. This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
1 tablet daily or as directed by a licensed medical practitioner.
76439-353-10
Rx
Prescription Folic Acid-Containing
Dietary Supplement
Virt-Gard is an orally administered prescription dietary supplement and should be administered under the supervision of a licensed medical practitioner.
| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Tablet | ||
| Amount Per Serving | % Daily Value* | |
Vitamin B6 | ||
(Pyridoxine HCl) | 25 mg | 1471% |
Folate (2200 mcg Folic Acid) | 3667 mcg DFE | 917% |
Vitamin B12 | ||
(Cyanocobalamin) | 1 mg | 41667% |
*Percent Daily Values are based on a 2,000 calorie diet. | ||
Other Ingredients: Dicalcium Phosphate, Microcrystalline Cellulose, Pregelatinized Starch, Pink Coating (Hypromellose, Polydextrose, Titanium Dioxide, Talc, Maltodextrin, Medium Chain Triglycerides, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1), Stearic Acid, Silicon Dioxide, Magnesium Stearate.
Virt-Gard tablets are indicated for nutritional support and folic acid supplementation. This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
This product is contraindicated in people with known history of hypersensitivity to any of the ingredients.
High levels of folic acid may, especially in older adults, hide signs of vitamin B-12 deficiency (such as pernicious anemia, a condition that can cause nerve damage).
Safety and effectiveness in pediatric patients have not been established.
Allergic sensitization has been reported following oral administration of folic acid. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride.
Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.
1 tablet daily or as directed by a licensed medical practitioner.
Supplied as round, pink tablets imprinted with "V353," dispensed in bottles of 100 tablets.
76439-353-10
Store at controlled room temperature 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion.
Call your licensed medical practitioner about side effects. You may report side effects by calling Virtus at 1-855-255-6076.
KEEP OUT OF REACH OF CHILDREN.
Rx
Manufactured for:
Virtus Pharmaceuticals OPCO II, LLC
Nashville, TN 37217
1-855-255-6076
Made in USA
Rev. 06/2018
VIRTUS®
PHARMACEUTICALS OPCO II
76439-353-10
Virt-Gard
Prescription Folic Acid-Containing
Dietary Supplement
Rx
100 Tablets
Made in USA
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 636528 | folic acid 2.2 MG / vitamin B 12 1 MG / vitamin B6 25 MG Oral Tablet | PSN | 4 |
| 636528 | folic acid 2.2 MG / vitamin B12 1 MG / vitamin B6 25 MG Oral Tablet | SCD | 4 |
| 636528 | cyanocobalamin 1 MG / folic acid 2.2 MG / pyridoxine 25 MG Oral Tablet | SY | 4 |
| 636528 | folate 2.2 MG / vitamin B12 1 MG / vitamin B6 25 MG Oral Tablet | SY | 4 |
| Class | Version | Type | Effective |
|---|---|---|---|
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76439-353-10 | Virt-Gard | 100 in 1 BOTTLE | TABLET | 100 | 4 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76439-353-10 | EA - Each | 76439-353 | 072e6302-f5a1-4a4a-ba70-76e147e804ca | 1 | 2015-11-12 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Cyanocobalamin | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| Folic Acid | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| Pyridoxine Hydrochloride | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| Cyanocobalamin | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| Folic Acid | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| Pyridoxine | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| Croscarmellose Sodium | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76439-353 | 76439-353-10 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE, FOR SUSPENSION / ORAL | 282 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, EXTENDED RELEASE / ORAL | 392 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | INJECTION / INTRAMUSCULAR | 1 %w/v | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / INTRAVITREAL | NA | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | SUSPENSION / ORAL | 150 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1576 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TROCHE / ORAL | 50 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 144 mg |
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 |
Adverse event summaries are temporarily unavailable. Other product information remains available.