Ventrixyl™ is indicated to provide vitamin supplements 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) Ventrixy™ caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.
Storage and handling
Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at controlled room temperature 20° to 25°C (68° to 77°F). [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.
Ventrixyl™ is indicated to provide vitamin supplements 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:
CONTRAINDICATIONS SECTION
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNING:
WARNINGS SECTION
Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B
12 is deficient.
Precautions:
PRECAUTIONS SECTION
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:
DRUG INTERACTIONS SECTION
Ventrixyl™ 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:
ADVERSE REACTIONS SECTION
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:
DOSAGE & ADMINISTRATION SECTION
One (1)
Ventrixy™ caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.
How Supplied:
HOW SUPPLIED SECTION
Ventrixyl™ are beige speckled, oblong, coated caplets in bottles containing 30 caplets – NDC 59088-186-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.
Storage
STORAGE AND HANDLING SECTION
Do not use if bottle seal is broken.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Store at controlled room temperature 20° to 25°C (68° to 77°F). [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.
Chronocap
SPL UNCLASSIFIED SECTION
Chronocap 1Chronocap 2
Ventrixyl™
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free:
1-877-921-7873
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