DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATIONUsual adult dose is one (1) tablet once or twice daily or asprescribed by licensed medical practitioner.

HOW SUPPLIED SECTION.

Folinex(TM) capsules are supplied as solid, opaque,white, oblong capsule with 916 printed on oneside, dispensed in child-resistant bottles of 30ct(72380-916-30).

OTHER SAFETY INFORMATION.

KEEP OUT OF THE REACH OF CHILDREN.Store at 20-25C (68-77F); excursions permittedto 15-30C (59-86F) [See USP Controlled RoomTemperature.] Protect from heat, light and moisture.Do not use if seal is broken or missing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Package Label. NDC 72380-916-30VIVERA(TM)PHARMACEUTICALSFolinex(TM)30 CapsulesDispensed by Prescription OnlySupplement FactsServing Size: Capsule Servings per container: 30 Amount Per Serving %Daily ValueVitamin 500 mg 555%(Ascorbic Acid)Vitamin B12 mg 41,666%(as Methylcobalamin)Vitamin MK7 100 mcg 83%Folate 1700 mcg DFE 425% (1 mg Folic Acid)Other ingredients: Gelatin, MagnesiumStearate, Microcrystalline Cellulose, DicalciumPhosphate, Silicon Dioxide, Titanium DioxideDosage: Adult dose is one (1) capsuleonce 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 20-25C (68-77F);excusions permitted to 15-30C (59-86F)[See USP Controlled Room Temperature.]Protect from heat, light and moistureManufactured for:Vivera Pharmaceuticals, Inc.11100 Greenstone Ave.Santa Fe Springs, CA 90670MADE IN THE U.S.A. REV120519LOT NO:EXP. DATE:MFG. DATE:3 72389 00004 9RES. Folinex.

PRECAUTIONS SECTION.

PRECAUTIONSTell your doctor if you have: kidney problems or thyroiddisease. This medication should be used as directedduring pregnancy or while breast-feeding. Consultyour doctor about the risks and benefits. Folic acid alone isimproper therapy in the treatment of pernicious anemiaand other megaloblastic anemias where vitamin B12 isdeficient. Folic acid in doses above 0.1 mg daily mayobscure pernicious anemia in that hematologic remissioncan occur while neurological manifestations progress.

PREGNANCY SECTION.

If you are pregnant or nursing, ask ahealthcare professional.

SPL UNCLASSIFIED SECTION.

FACTSFolinex(TM) is an orally administered prescription folateproduct for the dietary management of patients withunique nutritional needs requiring increased folatelevels and other nutritional supplementation.Folinex(TM) should be administered under the supervisionof licensed medical practitioner.Folinex(TM) is used for dietary management of patientswith unique nutritional needs requiring increasedfolate levels, or are in need of other nutritionalsupplementation. Folinex(TM) can be taken by womenof childbearing age, pregnant women, and lactatingand nonlactating mothers under the supervision of alicensed medical practitioner.

WARNINGS SECTION.

WARNINGSAllergic sensitization has been reported following bothoral and parenteral administration of folic acid. Youshould call your doctor for medical advice about seriousadverse events.