Dosage and administration
Adults (persons over 12 years of age) Two (2) Folitin-Z TM caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.
Folitin-Z
- Manufacturer
- PureTek Corporation
- Effective date
- 2024-12-02
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-05-31 21:18:37
Label at a glance#
ProductFolitin-Z
Active ingredientVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, PANTOTHENIC ACID, CALCIUM CARBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE, SELENIUM, CUPROUS OXIDE, MANGANESE SULFATE, CHROMIUM NICOTINATE, MOLYBDENUM, POTASSIUM CHLORIDE, BORON
Label structure10 sections
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 20o to 25oC (68o to 77oF). [See USP]. Protect from light and moisture and avoid excessive heat. To report a serious adverse event or to obtain product information, contact 1-877-921-7873.
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/medwatch
www.fda.gov/medwatchLabel contents#
Full prescribing information#
DESCRIPTION:
Full Prescribing Information:
Each Serving Size of 2 caplets contain:
Vitamin A (as Retinyl Acetate)................................................... 3000 mcg RAE
Vitamin C (as Ascorbic Acid)............................................................... 500 mg
Vitamin D (as Cholecalciferol).......................................... 3 27.5 mcg (1100 IU)
Vitamin E (as DL-alpha Tocopheryl Acetate)........................................... 90 mg
Thiamin (as Thiamine Mononitrate)....................................................... 6.5 mg
Riboflavin ............................................................................................. 6.7 mg
Niacin (as Niacinamide)......................................................................... 45 mg
Vitamin B6 (as Pyridoxine HCl)............................................................... 12 mg
Folate 1700 mcg DFE
(as L-5-Methyltetrahydrofolate calcium salt).........(1000 mcg as L-Methyfolate)
Vitamin B12 (as Methylcobalamin)....................................................... 26 mcg
Biotin ................................................................................................ 200 mcg
Pantothenic Acid (as Calcium Pantothenate)........................................... 30 mg
Calcium (as Calcium Carbonate)...........................................................150 mg
Iron (as Ferrous Fumarate)......................................................................18 mg
Iodine (as Potassium Iodide)................................................................50 mcg
Magnesium (as Magnesium Oxide)........................................................ 75 mg
Zinc (as Zinc Gluconate)......................................................................... 30 mg
Selenium (as Selenomethionine)...........................................................60 mcg
Copper (as Copper Oxide)....................................................................... 2 mg
Manganese (as Manganese Sulfate).......................................................1.5 mg
Chromium (as Chromium Polynicotinate)..............................................75 mcg
Molybdenum (as Sodium Molybdate)................................................... 50 mcg
Potassium (as Potassium Chloride)....................................................... 49 mg
Boron (as Boron Citrate)...................................................................... 50 mcg
Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake).
INDICATIONS:
Folitin-Z TM is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occurs together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.
CONTRAINDICATIONS:
This product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.
WARNING:
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.
Precaution 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 B12 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:
Folitin-Z TM 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:
Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.
Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving
Folitin-Z
TM
after meals may control occasional gastrointestinal disturbances.
Folitin-Z
TM
is best absorbed when taken at bedtime. 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 usually recommended levels, has been associated with gastrointestinal intolerance in some patients.
OVERDOSE:
Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness, and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Folitin-Z TM should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of reach of children.
Treatment:
For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.
DOSAGE AND ADMINISTRATION:
Adults (persons over 12 years of age) Two (2) Folitin-Z TM caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.
HOW SUPPLIED:
Folitin-Z TM are yellow with slightly brown speckled, coated caplets. Bottles contain 60 caplets – NDC 59088-181-58. 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 20o to 25oC (68o to 77oF). [See USP].
Protect from light and moisture and avoid excessive heat.
To report a serious adverse event or to obtain product information, contact
1-877-921-7873.
Chronocap
Folitin-Z TM
Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free:
1-877-921-7873
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASCORBIC ACID Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CALCIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230427 |
| CHOLECALCIFEROL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| MAGNESIUM CATION Pharmacologic Class Indexing | 4 | Indexing - Pharmacologic Class | 20180813 |
| MANGANESE CATION (2+) Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NIACIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| POTASSIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
| VITAMIN A Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59088-181-58 | Folitin-Z | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59088-181-58 | EA - Each | 59088-181 | 3a229124-2775-48f0-afc2-669956394eac | 1 | 2021-04-08 |
Products#
Every source-derived product name is available through these pages.
- Folitin-Z
- Ferrous Fumarate, Folic Acid
- MICROCRYSTALLINE CELLULOSE
- CROSPOVIDONE
- SILICON DIOXIDE
- MAGNESIUM STEARATE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- DEXTROSE MONOHYDRATE
- TITANIUM DIOXIDE
- ICODEXTRIN
- STEARIC ACID
- FD&C YELLOW NO. 6
- VITAMIN A ACETATE
- VITAMIN A
- ASCORBIC ACID
- CHOLECALCIFEROL
- .ALPHA.-TOCOPHEROL ACETATE, DL-
- .ALPHA.-TOCOPHEROL, DL-
- THIAMINE MONONITRATE
- THIAMINE ION
- THIAMINE
- RIBOFLAVIN
- NIACINAMIDE
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
- FOLIC ACID
- CYANOCOBALAMIN
- BIOTIN
- PANTOTHENIC ACID
- CALCIUM CARBONATE
- CALCIUM CATION
- FERROUS FUMARATE
- FERROUS CATION
- POTASSIUM IODIDE
- IODIDE ION
- MAGNESIUM OXIDE
- MAGNESIUM CATION
- ZINC OXIDE
- ZINC CATION
- SELENIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59088-181 | 59088-181-58 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Folitin-Z | FERROUS FUMARATE, FOLIC ACID | PureTek Corporation | bb141ac2-e5df-4df4-e053-2995a90a6e72 | 2024-12-02 | Warnings, Adverse reactions | 59088-181-58 59088-181 59088018158 284e5bd7-a49f-06f7-e063-6394a90ab1ba bb141ac2-e5df-4df4-e053-2995a90a6e72 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.