Label: FOLIFLEX- ferrous fumarate, folic acid tablet

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).

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.

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.

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.

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.

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.

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.

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.

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free:
1-877-921-7873