DaVITE: Package Insert and Label Information

DAVITE- ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin and pantothenic acid tablet, coated
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS

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.

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.

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

90 Tabs
(click image for full-size original)

DAVITE
ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cyanocobalamin, biotin, pantothenic acid tablet, coated
Product Information
Product Type Item Code (Source) NDC:73317-4826
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 100 mg
Thiamine Mononitrate (Thiamine Ion) Thiamine 1.5 mg
Riboflavin (Riboflavin) Riboflavin 1.7 mg
Niacinamide (Niacinamide) Niacinamide 20 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine 10 mg
Folic Acid (Folic Acid) Folic Acid 1000 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 6 ug
Biotin (Biotin) Biotin 150 ug
PANTOTHENIC ACID (PANTOTHENIC ACID) PANTOTHENIC ACID 5 mg
Inactive Ingredients
Ingredient Name Strength
Microcrystalline Cellulose
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
STEARIC ACID
Croscarmellose Sodium
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color yellow Score no score
Shape ROUND Size 11mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73317-4826-9 90 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 04/20/2020
Labeler — SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162)
Establishment
Name Address ID/FEI Operations
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS 081225162

Revised: 04/2020 SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS

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