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Vitrexyl
folic acid · Vitrexyl is a vitamin b12 (prescription) containing folic acid, made by PureTek Corporation.
- Type
- Prescription
- Drug class
- Vitamin B12
- Route
- Oral
- Manufacturers
- 1
Vitrexyl™ is indicated to provide vitamin supplement to men and women.
Drug facts
- Generic name
- folic acid
- Active ingredients
- .alpha.-Tocopherol Acetate, Dl-, Ascorbic Acid, Calcium Carbonate, Cholecalciferol, Chromium Nicotinate, Cyanocobalamin, Folic Acid, Magnesium Oxide, Manganese Sulfate, Molybdenum, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Selenium, Thiamine Mononitrate, Vitamin a Acetate, Zinc Oxide
- Drug class
- Vitamin B12Vitamin CVitamin D
- Dosage forms
- Tablet
- Label holder
- PureTek Corporation
- Label updated
- 01/11/2023
Uses
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.
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.
Contraindications
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Warnings
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.
Side effects (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.
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).
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).
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 and handling
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.
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet | 30 mg / 200 mg / 35 ug / 20 mg / 45 ug / 55 ug / 20 ug / 3.4 mg / 20 mg / 120 mg / 1000 ug / 8 ug / 200 mg / 1500 ug / 3 mg / 25 mg / 2.3 mg | oral | 1 |
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 247,883 reports that list folic acid, data through 07/30/2026
Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.
Most often reported reactions
- Drug ineffective25,265
- Fatigue23,920
- Pain23,617
- Arthralgia19,990
- Off label use18,070
- Rheumatoid arthritis17,937
- Nausea16,044
- Diarrhea14,601
- Headache14,599
- Rash14,021
To report a side effect, use FDA MedWatch.
Manufacturers and labels
1 FDA label
- PureTek CorporationShown hereLabel 01/11/2023 · NDC 59088-164Full label
Related recalls
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Vitrexyl: common questions
- What is Vitrexyl used for?
- Vitrexyl™ is indicated to provide vitamin supplement to men and women.
- What are the side effects of Vitrexyl?
- Allergic sensitization has been reported following both oral and parenteral administration of folic acid. See the full side effects section on this page, and ask your doctor or pharmacist about any side effect that bothers you.
- Is Vitrexyl a prescription drug?
- Yes. Vitrexyl is a prescription (Rx) drug.
- Are there other products with the same active ingredient as Vitrexyl?
- Yes. Other FDA-listed products with the same active ingredients include Multitam, Venexa, Ventrixyl, Vitramyn.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 01/11/2023 · Label text is shown as published by the manufacturer. Not medical advice