Xvite: Package Insert and Label Information

XVITE- ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, methylcobalamin, biotin and pantothenic acid tablet, film coated
Foxland Pharmaceuticals, Inc.

Dispensed by Prescription

Supplement Facts
Serving Size: 1 Tablet Servings per container: 30
Amount Per Serving: % Daily Value
*Daily Values (DV) not established.
Vitamin C (as ascorbic acid) 100 mg 167%
Thiamin (as thiamine mononitrate) 1.5 mg 100%
Riboflavin 1.7 mg 100%
Niacin (as niacinamide) 20 mg 100%
Vitamin B6 (as pyridoxine HCl) 10 mg 500%
Folic Acid 1 mg 250%
Vitamin B12 (as methylcobalamin) 6 mcg 100%
Biotin 300 mcg 100%
Pantothenic Acid
(as d-calcium pantothenate)
10 mg 100%

OTHER INGREDIENTS

cellulose, D&C Yellow #10, magnesium stearate, silicon dioxide, titanium dioxide.

DESCRIPTION

Xvite Tablets is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNINGS AND PRECAUTIONS

Xvite Tablets should only be used under the direction and supervision of a licensed medical practitioner.

Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking other medications.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Pregnancy and Lactation

Xvite Tablets are not intended for use in pregnant or lactating patients.

ADVERSE REACTIONS

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact Foxland Pharmaceuticals, Inc., Trussville, AL 35173.

DOSAGE AND ADMINISTRATION

Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed medical practitioner.

HOW SUPPLIED

Xvite Tablets are supplied as light yellow oblong tablets debossed with “040″ in a child-resistant bottle of 30ct (69067-040-30)

STORAGE

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]

Protect from heat, light and moisture.

KEEP OUT OF THE REACH OF CHILDREN.

Tamper Evident: Do not use if seal is broken or missing.

Manufactured for:
Foxland Pharmaceuticals, Inc.
Trussville, AL 35173

Rev. 08/18

Dispensed by Prescription 1


1
This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760).1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx). This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.
  1. Federal Register Notice of August 2, 1973 (38 FR 20750)
  2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
  3. Federal Register Notice of March 5, 1996 (61 FR 8760)

PRINCIPAL DISPLAY PANEL — 30 Tablet Bottle Label

69067-040-30

XVITE
Tablets

Dietary Supplement

Dispensed by Prescription

30 Tablets

Foxland
PHARMACEUTICALS, INC.

PRINCIPAL DISPLAY PANEL -- 30 Tablet Bottle Label
(click image for full-size original)
XVITE
ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, methylcobalamin, biotin, and pantothenic acid tablet, film coated
Product Information
Product Type Item Code (Source) NDC:69067-040
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 HYDROCHLORIDE 10 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1000 ug
METHYLCOBALAMIN (METHYLCOBALAMIN) METHYLCOBALAMIN 6 ug
BIOTIN (BIOTIN) BIOTIN 300 ug
PANTOTHENIC ACID (PANTOTHENIC ACID) PANTOTHENIC ACID 10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
POWDERED CELLULOSE
STEARIC ACID
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
TITANIUM DIOXIDE
CARAMEL
PIGMENT RED 5
Product Characteristics
Color BROWN (beige) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code 040
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69067-040-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Dietary Supplement 12/10/2018
Labeler — Foxland Pharmaceuticals, Inc. (079407828)

Revised: 12/2018 Foxland Pharmaceuticals, Inc.

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