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FACTSZyrexal™ is an orally administered prescription tabletformulation for the clinical dietary management ofsuboptimal nutritional status in patients where advancedfolate supplementation is required and nutritionalsupplementation in physiologically stressful conditions formaintenance of good health is needed.
Warnings And Precautions
WARNINGS AND PRECAUTIONSThis product is contraindicated in patients with a knownhypersensitivity to any of the ingredients. Zyrexal™ tabletsshould only be used under the direction and supervision of alicensed medical practitioner. Use with caution in patients thatmay have a medical condition, are pregnant, lactating, trying toconceive, 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 pregnancyor while breast-feeding. Consult your doctor about the risksand benefits. Folic acid alone is improper therapy in thetreatment of pernicious anemia and other megaloblasticanemias where vitamin B12 is deficient. Folic acid in dosesabove 0.1 mg daily may obscure pernicious anemia inthat hematologic remission can occur while neurologicalmanifestations progress.Allergic sensitization has been reported following both oraland parenteral administration of folic acid. You should callyour 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.
Dosage & Administration
DOSAGE & ADMINISTRATIONUsual adult dose is one (1) tablet once or twice daily or asprescribed by a licensed medical practitioner.*
HOW SUPPLIEDZyrexal™ tablets are supplied as a coated, white, flat, roundtablet with “915” printed on one side, dispensed in achild-resistant bottle of 30ct. (72380-915-10*)
Storage And Handling
STORAGE AND HANDLINGStore 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.
If you are pregnant or nursing, ask ahealthcare professional.
Other Safety Information
KEEP OUT OF THE REACH OF CHILDREN. Do not use ifseal is broken or missing.
* 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 withmasking of B12 deficiency (pernicious anemia). Based on our assess-ment of the risk of obscuring pernicious anemia, this product requireslicensed medical supervision, an Rx status, and a National Drug Code(NDC) – or similarly-formatted product code, as required by pedigreereporting requirements and supply-chain control as well as – in somecases, for insurance-reimbursement applications.
NDC# 72380-915-10VIVERA™PHARMACEUTICALSZyrexal™30 TabletsDispensed by Prescription OnlySupplement FactsServings size: 1 Tablet Servings per container: 30 Amount Per Serving %Daily ValueVitamin C (As Ascorbic Acid) 125mg 138%Thiamine (As Thiamine HCL) 25mg 2,083%Vitamin B6 (As Pyridoxal Phosphate) 12.5mg 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 DioxideDosage: Adult dose is one (1) tabletonce or twice daily or as prescribed by alicensed medical practitioner.If you are pregnant or nursing, ask ahealthcare professional.KEEP OUT OF REACH OF CHILDRENSTORAGE: Store at 20°-25°C (68°-77°F);excusions permitted to 15°-30°C (59°-86°F)[See USP Controlled Room Temperature.]Protect from heat, light , and moisture.Manufactured for:Vivera Pharmaceuticals, Inc.11100 Greenstone Ave.Santa Fe Springs, CA 90670MADE IN THE U.S.A.REV120519LOT NO:EXP. DATE:MFG. DATE:3 72380 00005 6RES
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