Label: FOLINEX- vitamin c, vitamin b12, vitamin k mk7, folate capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 72380-916-30 - Packager: Vivera Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated February 10, 2020
If you are a consumer or patient please visit this version.
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SPL UNCLASSIFIED SECTION
FACTS
Folinex™ is an orally administered prescription folate
product for the dietary management of patients with
unique nutritional needs requiring increased folate
levels and other nutritional supplementation.Folinex™ should be administered under the supervision
of a licensed medical practitioner.Folinex™ is used for dietary management of patients
with unique nutritional needs requiring increased
folate levels, or are in need of other nutritional
supplementation. Folinex™ can be taken by women
of childbearing age, pregnant women, and lactating
and nonlactating mothers under the supervision of a
licensed medical practitioner. -
PRECAUTIONS
PRECAUTIONS
Tell your doctor if you have: kidney problems or 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. - WARNINGS
- DOSAGE & ADMINISTRATION
- PREGNANCY
- OTHER SAFETY INFORMATION
- HOW SUPPLIED
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OTHER SAFETY INFORMATION
* This product is a prescription-folate with or without other dietary
ingredients 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 assessment 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. -
Package Label
NDC# 72380-916-30
VIVERA™
PHARMACEUTICALSFolinex™
30 Capsules
Dispensed by Prescription Only
Supplement Facts
Serving Size: 1 Capsule Servings per container: 30
Amount Per Serving %Daily Value
Vitamin 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, Magnesium
Stearate, Microcrystalline Cellulose, Dicalcium
Phosphate, Silicon Dioxide, Titanium DioxideDosage: Adult dose is one (1) capsule
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°-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. REV120519
LOT NO:
EXP. DATE:
MFG. DATE:3 72389 00004 9
RES
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INGREDIENTS AND APPEARANCE
FOLINEX
vitamin c, vitamin b12, vitamin k mk7, folate capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72380-916 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 355 mg METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN 1 mg VITAMIN K7 (UNII: HEE4JPA7DF) (VITAMIN K7 - UNII:HEE4JPA7DF) VITAMIN K7 100 ug FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape capsule Size 16mm Flavor Imprint Code 916 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72380-916-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/07/2020 Labeler - Vivera Pharmaceuticals, Inc. (081244342) Registrant - Vivera Pharmaceuticals, Inc. (081244342)