Folcyteine: Package Insert / Prescribing Info
Package insert / product label
Generic name: calcium citrate, cholecalciferol, folic acid, acetylcysteine and magnesium citrate
Dosage form: tablet
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Warnings:
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. 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. 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.
Folcyteine Description
Each caplet contains:
Vitamin D3 (as Cholecalciferol) ..... 20 mcg (800 IU)
Folate (as Folic Acid)...1,667 mcg DFE (1,000 mcg Folic Acid)
Calcium (as Calcium Citrate)..... 47 mg
Magnesium (as Magnesium Citrate)..... 16 mg
N-Acetyl-L-Cysteine..... 200 mg
Other Ingredients:
Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Sodium Carboxymethyl Starch, Stearic Acid, Coating: (Hydroxypropyl Methylcellulose, PEG-8).
Indications and Usage for Folcyteine
Folcyteine™ 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. Folcyteine™ is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
Adverse Reactions/Side Effects
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 PureTek Corporation, at 1-877-921-7873.
Folcyteine Dosage and Administration
One (1) Folcyteine™ caplet daily or as directed by a physician. Do not administer to children under the age of 12.
How is Folcyteine supplied
Folcyteine™ are pale yellow, clear coated caplets in bottles containing 30 caplets – NDC 59088-795-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.
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.
Manufactured by:
PureTek Corporation Panorama City, CA 91402
For questions or information call toll-free: 877-921-7873
| FOLCYTEINE
multivitamin tablet |
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| Labeler - PureTek Corporation (785961046) |