FOLCYTEINE- multivitamin tablet

Folcyteine by

Drug Labeling and Warnings

Folcyteine by is a Prescription medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

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.

BOXED WARNING

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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.

Adverse Reactions:

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.

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 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

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™

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873

INGREDIENTS AND APPEARANCE

FOLCYTEINE 
multivitamin tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 59088-795
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CITRATE	47 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	800 [iU]
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1000 ug
ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC)	ACETYLCYSTEINE	200 mg
MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CITRATE	16 mg

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	yellow (Pale Yellow)	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-795-54	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/14/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/14/2023

Labeler - PureTek Corporation (785961046)