ZYREXAL- viatmin c, thiamine, vitamin b6, folate,vitamin b12, vitamin b3, d-ribose, coenzyme q-10 tablet

Zyrexal by

Drug Labeling and Warnings

Zyrexal by is a Prescription medication manufactured, distributed, or labeled by Vivera Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

DOSAGE & ADMINISTRATION

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

HOW SUPPLIED

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

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

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

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

RES

INGREDIENTS AND APPEARANCE

ZYREXAL 
viatmin c, thiamine, vitamin b6, folate,vitamin b12, vitamin b3, d-ribose, coenzyme q-10 tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 72380-915
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	125 mg
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	25 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	12.5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W)	METHYLCOBALAMIN	1 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	60 mg
.BETA.-D-RIBOSE (UNII: IVV837V11N) (.BETA.-D-RIBOSE - UNII:IVV837V11N)	.BETA.-D-RIBOSE	50 mg
UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46)	UBIDECARENONE	75 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	16mm
Flavor		Imprint Code	915
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72380-915-10	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)