Folcyteine

Folcyteine
SPL v1
SPL
SPL Set ID 04cf0026-e29b-ffd5-e063-6294a90aca1f
Route
ORAL
Published
Effective Date 2023-09-11
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cholecalciferol (47 mg) Folic Acid (800 [iU]) Acetylcysteine (1000 ug) Magnesium Cation (200 mg)
Inactive Ingredients
Stearic Acid Polyethylene Glycol 400 Cellulose, Microcrystalline Sodium Starch Glycolate Type A Magnesium Stearate Hypromelloses Lactose Monohydrate

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: yellow Size: 22 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-09-14

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

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

Dosage and Administration

One (1) Folcyteine™ caplet daily 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. Folcyteine™ is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

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.

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.


Medication Information

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

Dosage and Administration

One (1) Folcyteine™ caplet daily 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. Folcyteine™ is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

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.

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.

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

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

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.

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

Folcyteine™

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

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.

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.

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.

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

Dosage and Administration:

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


Structured Label Content

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

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.

Description: (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

Folcyteine™

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

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.

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.

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.

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

Dosage and Administration:

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


Advanced Ingredient Data


Raw Label Data

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