DaVITE
- Manufacturer
- SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
- Effective date
- 2020-04-22
- Label type
- DIETARY SUPPLEMENT
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:34:34
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
DESCRIPTION
DaVite is a prescription folic acid supplement with additional nutrients for kidney dialysis patients. DaVite is a small, round, yellow tablet
Each tablet contains:
Vitamin C (Ascorbic Acid).....100 mg
Vitamin B1 (Thiamine).....1.5 mg
Vitamin B2 ( Riboflavin) .....1.7 mg
Vitamin B3 (Niacinamide).....20 mg
Vitamin B6 (Pyridoxine HCl).....10 mg
Folic Acid.....1000 mcg
Vitamin B12 (Cyanocobalamin).....6 mcg
Biotin.....150 mcg
Pantothenic Acid .....5 mg
Inactive ingredients:
Microcrystalline Cellulose, Dicalcium Phosphate, Stearic Acid, Croscarmellose Sodium, Magnesium Stearate, Silicon Dioxide, Opadry II Yellow (color).
INDICATIONS AND USAGE
DaVite is a prescription folic acid supplement with additional nutrients indicated for use in improving the nutritional status of renal dialysis patients.
CONTRAINDICATIONS
This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
WARNINGS SECTION
WARNING
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.
PRECAUTIONS
Folic Acid
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using these products since folic acid may mask the symptoms of pernicious anemia.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.
ADVERSE REACTIONS
Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DRUG INTERACTIONS
Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.
OVERDOSAGE
Symptoms: abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrohosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.
DOSAGE AND ADMINISTRATION
One tablet daily or as directed by a physician.
NOTICE Contact with moisture can discolor or erode the tablet. Do not chew tablet.
HEALTH CLAIM SECTION
STORAGE
Store at 20°-25°C (66°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Protect from heat, light and moisture.
HOW SUPPLIED
Bottles of 90 tablets each - NDC 73317-4826-9
DaVite Tablets
Multivitamin Supplement for Dialysis Patients
To report a serious adverse event or obtain product information, call (866)-760-6565
Call your licensed medical practitioner about side effect.
You may report side effects by calling AUM 866-760-6565.
Manufactured and Distributed by:
AUM Pharmaceuticals
Hauppauge, NY 11788.
Made in USA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- DaVITE
- Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cyanocobalamin, Biotin, Pantothenic Acid
- Ascorbic Acid
- Thiamine Mononitrate
- Thiamine Ion
- Thiamine
- Riboflavin
- Niacinamide
- Pyridoxine Hydrochloride
- Pyridoxine
- Folic Acid
- CYANOCOBALAMIN
- Biotin
- PANTOTHENIC ACID
- Microcrystalline Cellulose
- CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
- STEARIC ACID
- Croscarmellose Sodium
- MAGNESIUM STEARATE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73317-4826 | 73317-4826-9 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Ascorbic Acid | PQ6CK8PD0R | ACTIB |
| Thiamine Mononitrate | 8K0I04919X | ACTIR |
| Riboflavin | TLM2976OFR | ACTIB |
| Niacinamide | 25X51I8RD4 | ACTIB |
| Pyridoxine Hydrochloride | 68Y4CF58BV | ACTIM |
| Folic Acid | 935E97BOY8 | ACTIB |
| CYANOCOBALAMIN | P6YC3EG204 | ACTIB |
| Biotin | 6SO6U10H04 | ACTIB |
| PANTOTHENIC ACID | 19F5HK2737 | ACTIB |
| Microcrystalline Cellulose | OP1R32D61U | IACT |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | L11K75P92J | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| Croscarmellose Sodium | M28OL1HH48 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | 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 |
|---|---|---|---|---|---|---|
| Ascorbic Acid | ASCORBIC ACID | Renova Pharmaceuticals LLC | a6481bae-2397-44c7-a51d-4f47ad91bd2c | 2026-08-19 | Warnings, Adverse reactions | ASCORBIC ACID |
| Ascor | ASCORBIC ACID | McGuff Pharmaceuticals, Inc. | 388aad52-fc01-4784-9791-1dbc80c69306 | 2026-05-29 | Warnings, Adverse reactions | ASCORBIC ACID |
| Ascorbic Acid | ASCORBIC ACID | Fresenius Kabi USA, LLC | 1606e29f-0e80-4069-b688-daab9cbff20a | 2025-12-17 | Warnings, Adverse reactions | ASCORBIC ACID |
| Skin Renewing Serum | ASCORBIC ACID | Guangzhou Danting Bath&Body Care Industry Co. Ltd | 396c2a8d-ac95-cbef-e063-6294a90aff39 | 2025-08-23 | Warnings | ASCORBIC ACID |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
