Drugplain

Foliflex 45 mg/1

Ferrous Fumarate, Folic Acid · TABLET · PureTek Corporation

No Recall History
Plain English

Foliflex is a tablet containing ferrous fumarate, folic acid at 45 mg/1, taken oral. Manufactured by PureTek Corporation.

Key Facts

Brand Name
Foliflex
Generic Name
Ferrous Fumarate, Folic Acid
NDC Code (Product)
59088-480
Manufacturer
PureTek Corporation
Strength
45 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Drug Class
Vitamin C [EPC]; Vitamin D [EPC]
Marketing Start
10/25/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

blood creatinine increased1 reports
blood urea increased1 reports
calciphylaxis1 reports
cerebral ischaemia1 reports
circulatory collapse1 reports
diabetic ulcer1 reports
dialysis1 reports
infection1 reports
international normalised ratio increased1 reports
rectal haemorrhage1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS: 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.

Dosage & Administration

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.

Warnings

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 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 yo

Contraindications

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.

Drug Interactions

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

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.

Frequently Asked Questions

What is Foliflex used for?

Foliflex contains Ferrous Fumarate, Folic Acid. It is a tablet taken oral. Consult your doctor for specific uses.

Is Foliflex a controlled substance?

Foliflex is not classified as a controlled substance by the DEA.

What is the generic name for Foliflex?

The generic name for Foliflex is Ferrous Fumarate, Folic Acid. There are 11 other brand versions of Ferrous Fumarate, Folic Acid.

What is the NDC code for Foliflex 45 mg/1?

The NDC (National Drug Code) for Foliflex 45 mg/1 is 59088-480, listed by PureTek Corporation.