Zyrexal

Manufacturer
Vivera Pharmaceuticals, Inc.
Effective date
2020-02-10
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:32:15

Label at a glance#

ProductZyrexal
Active ingredientASCORBIC ACID, THIAMINE HYDROCHLORIDE, PYRIDOXINE, FOLIC ACID, METHYLCOBALAMIN, NIACINAMIDE, .BETA.-D-RIBOSE, UBIDECARENONE
Label structure9 sections

Storage and handling

STORAGE AND HANDLING 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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

FACTS

Zyrexal™ is an orally administered prescription tablet
formulation for the clinical dietary management of
suboptimal nutritional status in patients where advanced
folate supplementation is required and nutritional
supplementation in physiologically stressful conditions for
maintenance of good health is needed.

WARNINGS AND PRECAUTIONS SECTION

WARNINGS AND PRECAUTIONS

This product is contraindicated in patients with a known
hypersensitivity to any of the ingredients. Zyrexal™ tablets
should only be used under the direction and supervision of a
licensed medical practitioner. Use with caution in patients that
may have a medical condition, are pregnant, lactating, trying to
conceive, 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 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.

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.
To report adverse side effects or to obtain product information,
contact Vivera™ Pharmaceuticals, at 1-844-484-8372.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION

Usual adult dose is one (1) tablet once or twice daily or as
prescribed by a licensed medical practitioner.*

HOW SUPPLIED SECTION

HOW SUPPLIED
Zyrexal™ tablets are supplied as a coated, white, flat, round
tablet with “915” printed on one side, dispensed in a
child-resistant bottle of 30ct. (72380-915-10*)

STORAGE AND HANDLING SECTION

STORAGE AND HANDLING
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.

PREGNANCY SECTION

If you are pregnant or nursing, ask a
healthcare professional.

OTHER SAFETY INFORMATION

KEEP OUT OF THE REACH OF CHILDREN. Do not use if
seal is broken or missing.

OTHER SAFETY INFORMATION

* 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 with
masking of B12 deficiency (pernicious anemia). Based on our assess-
ment 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 72380-915-10

VIVERA™
PHARMACEUTICALS

Zyrexal™

30 Tablets

Dispensed by Prescription Only

Supplement Facts
Servings size: 1 Tablet                               Servings per container: 30
                                                Amount Per Serving      %Daily Value
Vitamin 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 Dioxide

Dosage: 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 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  72380 00005  6

Zyrexal 916-30Zyrexal 916-30

RES

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72380-915-102021-07-23C16284748780-1c7ccaba7-2826-fd44-e053-dadaa90aa01bZyrexal TM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72380-915-10Zyrexal30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72380-915ZYREXAL (VIATMIN C, THIAMINE, VITAMIN B6, FOLATE,VITAMIN B12, VITAMIN B3, D-RIBOSE, COENZYME Q-10) TABLET [VIVERA PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20200211_27f61816-57bb-4638-a575-bf8be1562aed.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72380-91572380-915-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ed44e259-cdcd-47a7-9538-ad4d1f80c75b27f61816-57bb-4638-a575-bf8be1562aed2020-02-10WarningsExact identifier
spl id: ed44e259-cdcd-47a7-9538-ad4d1f80c75b
spl set id: 27f61816-57bb-4638-a575-bf8be1562aed

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.