SPL UNCLASSIFIED SECTION.
FACTS Zyrexal is an orally administered prescription tablet formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.
HOW SUPPLIED SECTION.
HOW SUPPLIED Zyrexal tablets are supplied as a coated, white, flat, round tablet with 915 printed on one side, dispensed in a child-resistant bottle of 30ct. (72380-915-10*)
STORAGE AND HANDLING SECTION.
STORAGE AND HANDLING Store at 20-25C (68-77F); excursions permitted to 15- 30C (59-86F) [See USP Controlled Room Temperature.] Protect from heat, light and moisture.
If you are pregnant or nursing, ask a healthcare professional.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE & ADMINISTRATION Usual adult dose is one (1) tablet once or twice daily or as prescribed by a licensed medical practitioner.*
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Package Label NDC# 72380-915-10 VIVERA PHARMACEUTICALS Zyrexal 30 Tablets Dispensed by Prescription Only Supplement Facts Servings size: 1 Tablet Servings per container: 30 Amount Per Serving %Daily Value Vitamin C (As Ascorbic Acid) 125mg 138% Thiamine (As Thiamine HCL) 25mg 2,083% Vitamin B6 (As Pyridoxal Phosphate) 12.5 mg 735% Folate 1700 mcg DFE 425% (1 mg Folic Acid) Vitamin B12 (As Methylcobalamin) 1mg 41,666% Vitamin B3 (As Niacinamide) 60mg 375% D-Ribose 50mg * CoEnzyme Q-10 (As Ubiquinone) 75mg * * % Daily Values have not been established. Other ingredients: Microcrystalline Cellulose, Magnesium Stearate, Silicone Dioxide Dosage: Adult dose is one (1) tablet once or twice daily or as prescribed by a licensed medical practitioner. If you are pregnant or nursing, ask a healthcare professional. KEEP OUT OF REACH OF CHILDREN STORAGE: Store at 20-25C (68-77F); excusions permitted to 15-30C (59-86F) [See USP Controlled Room Temperature.] Protect from heat, light , and moisture. Manufactured for: Vivera Pharmaceuticals, Inc. 11100 Greenstone Ave. Santa Fe Springs, CA 90670 MADE IN THE U.S.A. REV120519 LOT NO: EXP. DATE: MFG. DATE: 3 72380 00005 6 RES
OTHER SAFETY INFORMATION.
* This product is a prescription-folate with or without other dietary in- gredients that due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assess- ment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) or similarly-formatted product code, as required by pedigree reporting requirements and supply-chain control as well as in some cases, for insurance-reimbursement applications.
WARNINGS AND PRECAUTIONS SECTION.
WARNINGS AND PRECAUTIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Zyrexal 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 medications. 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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact Vivera Pharmaceuticals, at 1-844-484-8372.