Venexa FE

VENEXA FE- chromium nicotinate, folic acid, vitamin a acetate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, calcium carbonate, ascorbic acid, thiamine mononitrate, zinc oxide, manganese sulfate, ferrous fumarate, magnesium oxide, molybdenum, .alpha.-tocopherol acetate, dl-, cholecalciferol and selenium tablet
PureTek Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION:

Each caplet contains:

Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU)
Vitamin C (as ascorbic acid)……………………………… 120 mg
Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU)
Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU)
Thiamin (as thiamine mononitrate)…………………………. 3 mg
Riboflavin (vitamin B2)……………………………………. 3.4 mg
Niacin (as niacinamide)…………………………………… 20 mg
Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg
Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid)
Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg
Calcium (as calcium carbonate)…………………………. 200 mg
Iron (as ferrous fumarate)………………………………… 27 mg
Magnesium (as magnesium oxide)……………………… 200 mg
Zinc (as zinc oxide)……………………………………….. 25 mg
Selenium (as selenium amino acid chelate)………………. 55 mcg
Manganese (as manganese sulfate)……………………… 2.3 mg
Chromium (as chromium polynicotinate)……………….. 35 mcg
Molybdenum (as molybdenum amino acid chelate)……… 45 mcg

Other Ingredients:
Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate,
microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl
methylcellulose, PEG-8).

INDICATIONS:

Venexa FE 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 treatment of 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 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.

Precaustion 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:

Venexa FE 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 Venexa FE after meals may
control occasional gastrointestinal disturbances. Venexa FE 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 usual 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. Venexa FE 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) One (1) Venexa FE caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.

HOW SUPPLIED:

Venexa FE are beige speckled, oblong, coated caplets, in bottles containing 30 caplets –NDC 59088-177-54. 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:

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.

Venexa FE

Manufactured by:
PureTek Corporation
Panorama City, CA 91402
For questions or information call toll-free: 877-921-7873

Label
(click image for full-size original)
VENEXA FE ferrous fumarate, folic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59088-177
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHROMIUM NICOTINATE (CHROMIC CATION) CHROMIUM NICOTINATE 35 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 1000 ug
VITAMIN A ACETATE (VITAMIN A) VITAMIN A 1500 ug
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 20 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 8 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 3 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 25 mg
MANGANESE SULFATE (MANGANESE CATION (2+)) MANGANESE CATION (2+) 2.3 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 27 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 200 mg
MOLYBDENUM (MOLYBDENUM) MOLYBDENUM 45 ug
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 30 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 20 ug
SELENIUM (SELENIUM) SELENIUM 55 ug
Inactive Ingredients
Ingredient Name Strength
STEARIC ACID
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL 400
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
COCOA
CROSPOVIDONE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color yellow Score no score
Shape CAPSULE (Oblong Tablet) Size 19mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59088-177-54 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/29/2021
Labeler — PureTek Corporation (785961046)
Establishment
Name Address ID/FEI Operations
PureTek Corporation 785961046 manufacture (59088-177), pack (59088-177), label (59088-177), relabel (59088-177), repack (59088-177)

Revised: 05/2021 PureTek Corporation

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