Label: ZYREXAL- viatmin c, thiamine, vitamin b6, folate,vitamin b12, vitamin b3, d-ribose, coenzyme q-10 tablet
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated February 10, 2020
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SPL UNCLASSIFIED SECTION
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
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
- HOW SUPPLIED
- STORAGE AND HANDLING
- OTHER SAFETY INFORMATION
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.
Dispensed by Prescription Only
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
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.
Vivera Pharmaceuticals, Inc.
11100 Greenstone Ave.
Santa Fe Springs, CA 90670
MADE IN THE U.S.A.
3 72380 00005 6
INGREDIENTS AND APPEARANCE
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)