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Folinex

Generic name: ascorbic acid, methylcobalamin, vitamin k7 and folic acid
Dosage form: capsule
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Feb 1, 2020.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

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

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.

DOSAGE AND ADMINISTRATION

Usual 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 THE REACH OF CHILDREN.

Store 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.

Do not use if seal is broken or missing.

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

* 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™
PHARMACEUTICALS

Folinex™

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 Dioxide

Dosage: 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 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 72389 00004 9

RES

Folinex
vitamin c, vitamin b12, vitamin k mk7, folate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:72380-916
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 355 mg
METHYLCOBALAMIN (METHYLCOBALAMIN) METHYLCOBALAMIN 1 mg
VITAMIN K7 (VITAMIN K7) VITAMIN K7 100 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SILICON DIOXIDE
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape capsule Size 16mm
Flavor Imprint Code 916
Contains
Packaging
# Item Code Package Description
1 NDC:72380-916-30 30 CAPSULE in 1 BOTTLE
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)
Vivera Pharmaceuticals, Inc.

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