Lexazin Capsules: Package Insert / Prescribing Info

HEALTH CLAIM:

Lexazin Capsule

Dispensed by Prescription†

OTHER INGREDIENTS: Yellow Wax(bees), Gelatin(bovine), Soybean Oil, Glycerin, Deionized Water, Lecithin(soy), Titanium Dioxide

DESCRIPTION:

Lexazin is an orally administered prescription Vitamin for the dietary management of patients with unique nutritional needs requiring increased folate levels and other nutritional supplementation. Lexazin should be administered under the supervision of a licensed medical practitioner.

Warnings and Precautions

Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits.

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 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Lexazin Capsules Dosage and Administration

Take 1 to 2 capsule daily as directed by a physician.

HOW SUPPLIED HEALTH CLAIM:

Lexazin capsules are supplied as white capsules printed with 356 dispensed in HDPE plastic bottles of 30ct.

NDC 69336-358-30

Reserved for Professional RecommendationAll prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

STORAGE AND HANDLING:

Store at controlled room temperature 15°-30°C (59°F-86°F).

Keep in cool dry place.

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

ADVERSE REACTIONS:

This medication is generally well tolerated. Notify your doctor if you experience: nausea, loss of appetite, vomiting, stomach cramps, dry mouth, increased thirst, increased urination, muscle or bone pain, headache, weakness, weight loss, dizziness. If you notice other effects not listed above, contact your doctor or pharmacist.

CONTRAINDICATIONS:

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

INDICATIONS AND USAGE:

Lexazin is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and other nutritional supplementation.

Display Package