Foliflex: Package Insert / Prescribing Info
Package insert / product label
Dosage form: tablet
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Foliflex 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 D3 (as Cholecalciferol) 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 and Usage for Foliflex
Foliflex 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 occur 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 folate may obscure its signs and symptoms.
Warnings
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 folate alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.
Precaution Section
Folate 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 folate to patients with undiagnosed anemia, since folate 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:
Foliflex 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:
Folate: Allergic sensitizations have been reported following both oral and parenteral administration of folate.
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
Foliflex
TM after meals may control occasional gastrointestinal disturbances.
Foliflex
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.
Overdosage
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. Foliflex 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.
Foliflex Dosage and Administration
Adults (persons over 12 years of age) Two (2) Foliflex TM caplet daily, between meals, or as directed by a physician. Do not administer to children under the age of 12.
How is Foliflex supplied
Foliflex TM are yellow with slightly brown speckled, oblong, coated caplets. Bottles contain 60 caplets – NDC 59088-480-58. 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 and Handling
Do not use it if the 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
1-877-921-7873.
| FOLIFLEX
ferrous fumarate, folic acid tablet |
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| Labeler - PureTek Corporation (785961046) |