HEALTH CLAIM:

Zavitrol Capsule Dietary Supplement

Dispensed by Prescription†

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

DESCRIPTION:

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

WARNING 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.

DOSAGE & ADMINISTRATION:

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

HOW SUPPLIED HEALTH CLAIM:

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

NDC 69336-357-30

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:

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

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