The following Structured Product Label (SPL) was submitted to the FDA by Vivera Pharmaceuticals, Inc. for the product Zyrexal (NDC 72380-915). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, warnings and precautions, dosage & administration, how supplied, storage and handling, pregnancy, other safety information, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
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
Usual adult dose is one (1) tablet once or twice daily or as
prescribed by a licensed medical practitioner.*
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
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.
If you are pregnant or nursing, ask a
healthcare professional.
KEEP OUT OF THE REACH OF CHILDREN. Do not use if
seal is broken or missing.
* 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.
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
* Please review the disclaimer below.
