NDC 72380-915 Zyrexal

Viatmin C, Thiamine, Vitamin B6, Folate, Vitamin B12, Vitamin B3, D-ribose, Coenzyme Q-10

NDC Product Code 72380-915

NDC CODE: 72380-915

Proprietary Name: Zyrexal What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Viatmin C, Thiamine, Vitamin B6, Folate, Vitamin B12, Vitamin B3, D-ribose, Coenzyme Q-10 What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Drug uses not available
  • Folic acid is the man-made form of folate. Folate is a B-vitamin naturally found in some foods. It is needed to form healthy cells, especially red blood cells. Folic acid supplements may come in different forms (such as L-methylfolate, levomefolate, methyltetrahydrofolate). They are used to treat or prevent low folate levels. Low folate levels can lead to certain types of anemia. Conditions that can cause low folate levels include poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, among others. Women of childbearing age should receive adequate amounts of folic acid either through their diet or supplements to prevent infant spinal cord birth defects.
  • Niacinamide (nicotinamide) is a form of vitamin B3 (niacin) and is used to prevent and treat niacin deficiency (pellagra). Niacin deficiency can cause diarrhea, confusion (dementia), tongue redness/swelling, and peeling red skin. Niacinamide is often used instead of niacin because it causes fewer side effects (e.g., flushing). Unlike niacin, niacinamide does not help correct blood fat levels and cannot be substituted for niacin if you are being treated for a blood fat problem (e.g., high cholesterol). Niacin deficiency may happen as a result of poor diet, certain medical conditions (e.g., alcohol abuse, malabsorption syndrome, Hartnup disease), or long-term use of certain medications (e.g., isoniazid). It is best to get your vitamins from healthy foods. A multivitamin may be recommended by your doctor instead of niacinamide because poor diet usually causes deficiencies in more than one vitamin. Vitamins help to support the body's ability to make and break down natural substances (metabolism) and are needed for good health.
  • Coenzyme Q10 has been used for heart problems (e.g., heart failure, angina), high blood pressure, Parkinson's disease, gum disease, and certain diseases passed down through families (Huntington's disease, muscular dystrophy). It has also been used for reducing the number of migraine headaches and for reducing cell damage that may occur after surgery or treatment with certain anti-cancer drugs. If you have or think you have any of the conditions listed above, consult your doctor for advice on proper care and treatment. Coenzyme Q10 is a substance that your body normally makes. Your body uses it to help keep in good health. Some herbal/diet supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use. The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

NDC Code Structure

  • 72380 - Vivera Pharmaceuticals, Inc.

NDC 72380-915-10

Package Description: 30 TABLET in 1 BOTTLE

NDC Product Information

Zyrexal with NDC 72380-915 is a a human prescription drug product labeled by Vivera Pharmaceuticals, Inc.. The generic name of Zyrexal is viatmin c, thiamine, vitamin b6, folate, vitamin b12, vitamin b3, d-ribose, coenzyme q-10. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Vivera Pharmaceuticals, Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Zyrexal Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ASCORBIC ACID 125 mg/1
  • THIAMINE HYDROCHLORIDE 25 mg/1
  • PYRIDOXINE 12.5 mg/1
  • FOLIC ACID 1 mg/1
  • METHYLCOBALAMIN 1 mg/1
  • NIACINAMIDE 60 mg/1
  • .BETA.-D-RIBOSE 50 mg/1
  • UBIDECARENONE 75 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Ascorbic Acid - [CS]
  • Vitamin B6 Analog - [EPC] (Established Pharmacologic Class)
  • Vitamin B 6 - [Chemical/Ingredient]
  • Analogs/Derivatives - [Chemical/Ingredient]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Vivera Pharmaceuticals, Inc.
Labeler Code: 72380
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-07-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Zyrexal Product Label Images

Zyrexal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

FACTSZyrexal™ is an orally administered prescription tabletformulation for the clinical dietary management ofsuboptimal nutritional status in patients where advancedfolate supplementation is required and nutritionalsupplementation in physiologically stressful conditions formaintenance of good health is needed.

Warnings And Precautions

WARNINGS AND PRECAUTIONSThis product is contraindicated in patients with a knownhypersensitivity to any of the ingredients. Zyrexal™ tabletsshould only be used under the direction and supervision of alicensed medical practitioner. Use with caution in patients thatmay have a medical condition, are pregnant, lactating, trying toconceive, 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 pregnancyor while breast-feeding. Consult your doctor about the risksand benefits. Folic acid alone is improper therapy in thetreatment of pernicious anemia and other megaloblasticanemias where vitamin B12 is deficient. Folic acid in dosesabove 0.1 mg daily may obscure pernicious anemia inthat hematologic remission can occur while neurologicalmanifestations progress.Allergic sensitization has been reported following both oraland parenteral administration of folic acid. You should callyour 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 & ADMINISTRATIONUsual adult dose is one (1) tablet once or twice daily or asprescribed by a licensed medical practitioner.*

How Supplied

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

Storage And Handling

STORAGE AND HANDLINGStore 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 ahealthcare professional.

Other Safety Information

KEEP OUT OF THE REACH OF CHILDREN. Do not use ifseal 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 withmasking of B12 deficiency (pernicious anemia). Based on our assess-ment of the risk of obscuring pernicious anemia, this product requireslicensed medical supervision, an Rx status, and a National Drug Code(NDC) – or similarly-formatted product code, as required by pedigreereporting requirements and supply-chain control as well as – in somecases, for insurance-reimbursement applications.

Package Label

NDC# 72380-915-10VIVERA™PHARMACEUTICALSZyrexal™30 TabletsDispensed by Prescription OnlySupplement FactsServings size: 1 Tablet                               Servings per container: 30                                                Amount Per Serving      %Daily ValueVitamin 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 DioxideDosage: Adult dose is one (1) tabletonce or twice daily or as prescribed by alicensed medical practitioner.If you are pregnant or nursing, ask ahealthcare professional.KEEP OUT OF REACH OF CHILDRENSTORAGE: 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 90670MADE IN THE U.S.A.REV120519LOT NO:EXP. DATE:MFG. DATE:3  72380 00005  6RES

* Please review the disclaimer below.