The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
FACTSFolinex™ is an orally administered prescription folateproduct for the dietary management of patients withunique nutritional needs requiring increased folatelevels and other nutritional supplementation.Folinex™ should be administered under the supervisionof a licensed medical practitioner.Folinex™ is used for dietary management of patientswith unique nutritional needs requiring increasedfolate levels, or are in need of other nutritionalsupplementation. Folinex™ can be taken by womenof childbearing age, pregnant women, and lactatingand nonlactating mothers under the supervision of alicensed medical practitioner.
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.
WARNINGSAllergic sensitization has been reported following bothoral and parenteral administration of folic acid. Youshould call your doctor for medical advice about seriousadverse events.
Dosage & Administration
DOSAGE AND ADMINISTRATIONUsual adult dose is one (1) tablet once or twice daily or asprescribed by a licensed medical practitioner.*
If you are pregnant or nursing, ask ahealthcare professional.
Other Safety Information
KEEP OUT OF THE REACH OF CHILDREN.Store at 20°-25°C (68°-77°F); excursions permittedto 15°-30°C (59°-86°F) [See USP Controlled RoomTemperature.] Protect from heat, light and moisture.Do not use if seal is broken or missing.
* This product is a prescription-folate with or without other dietaryingredients that – due to increased folate levels (AUG 2 1973 FR20750), requires an Rx on the label because of increased riskassociated with masking of B12 deficiency (pernicious anemia). Basedon our assessment of the risk of obscuring pernicious anemia, thisproduct requires licensed medical supervision, an Rx status, and aNational Drug Code (NDC) – or similarly-formatted product code, asrequired by pedigree reporting requirements and supply-chain controlas well as – in some cases, for insurance-reimbursement applications.
Folinex™ capsules are supplied as a solid, opaque,white, oblong capsule with “916” printed on oneside, dispensed in child-resistant bottles of 30ct(72380-916-30*).
NDC# 72380-916-30VIVERA™PHARMACEUTICALSFolinex™30 CapsulesDispensed by Prescription OnlySupplement FactsServing Size: 1 Capsule Servings per container: 30 Amount Per Serving %Daily ValueVitamin C 500 mg 555%(Ascorbic Acid)Vitamin B12 1 mg 41,666%(as Methylcobalamin)Vitamin K 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°-25°C (68°-77°F);excusions permitted to 15°-30°C (59°-86°F)[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
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