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Vitrexyl Package Insert

Status:
Prescription (Rx) Facts
Strength:
30 mg, 200 mg, 35 mcg, 20 mg, 45 mcg, 55 mcg, 20 mcg, 3.4 mg, 20 mg, 120 mg, 1000 mcg, 8 mcg, 200 mg, 1500 mcg, 3 mg, 25 mg, 2.3 mg
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Vitrexyl

DESCRIPTION:

Each caplet contains:

Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU)

Vitamin C (as ascorbic acid)……………………………… 120 mg

Vitamin D3 (as cholecalciferol)…………………. 20 mcg (800 IU)

Vitamin E (dl-alpha tocopheryl acetate)……………. 30 mg (30IU)

Thiamin (as thiamine mononitrate)………………………… 3 mg

Riboflavin (vitamin B2)……………………………………. 3.4 mg

Niacin (as niacinamide)…………………………………… 20 mg

Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg

Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid)

Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg

Calcium (as calcium carbonate)…………………………. 200 mg

Magnesium (as magnesium oxide)……………………… 200 mg

Zinc (as zinc oxide)……………………………………….. 25 mg

Selenium (as selenium amino acid chelate)………………. 55 mcg

Manganese (as manganese sulfate)……………………… 2.3 mg

Chromium (as chromium polynicotinate)……………….. 35 mcg

Molybdenum (as molybdenum amino acid chelate)……… 45 mcg

Other Ingredients:

Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl methylcellulose, PEG-8).

INDICATIONS:

Vitrexyl™ is indicated to provide vitamin supplement to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

CONTRAINDICATIONS:

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING:

Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

PRECAUTIONS:

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

There is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B 12 may

prevent, halt, or improve the neurologic changes caused by pernicious anemia.

The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

For use on the order of a healthcare practitioner.

Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions:

Vitrexyl™ is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin or Clopidogrel).

Adverse Reactions:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

DOSAGE AND ADMINISTRATION:

One (1) Vitrexyl™ caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.

HOW SUPPLIED:

Vitrexyl™ are yellow to brown speckled, oblong, coated caplets with "PT A16" debossed horizontally on one side, bottles containing 30 caplets – NDC 59088-164-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

Store at controlled room temperature 20º-25ºC (68º-77ºF). [See USP]. Protect from light and moisture and avoid excessive heat.

Storage

Do not use if bottle seal is broken.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at controlled room temperature 20º-25ºC (68º-77ºF). [See USP].

Protect from light and moisture and avoid excessive heat.

To report a serious adverse event or to obtain product information, contact

877-921-7873.

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Vitrexyl

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Blood Coagulation Factor, Calculi Dissolution Agent, Copper Absorption Inhibitor, Osmotic Laxative, Paramagnetic Contrast Agent, Vitamin A, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Alpha-tocopherol acetate, DL- 30 mg, Magnesium oxide 200 mg, Chromium nicotinate 35 mcg, Pyridoxine hydrochloride 20 mg, Molybdenum 45 mcg, Selenium 55 mcg, Cholecalciferol 20 mcg, Riboflavin 3.4 mg, Niacinamide 20 mg, Ascorbic acid 120 mg, Folic acid 1000 mcg, Cyanocobalamin 8 mcg, Calcium carbonate 200 mg, Vitamin A acetate 1500 mcg, Thiamine mononitrate 3 mg, Zinc oxide 25 mg, Manganese sulfate 2.3 mg
Dosage form Tablet
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) PureTek Corporation
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
30 mg, 200 mg, 35 mcg, 20 mg, 45 mcg, 55 mcg, 20 mcg, 3.4 mg, 20 mg, 120 mg, 1000 mcg, 8 mcg, 200 mg, 1500 mcg, 3 mg, 25 mg, 2.3 mg – 30 in 1 bottle, plastic NDC 59088-164-54

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.