Prescribing information (package insert) - PNV Prenatol
Active Ingredients:
Each tablet contains:
Vitamin A (as retinyl acetate)…………...1500 mcg RAE (5000 IU)
Vitamin C (as ascorbic acid)……………….………………. 120 mg
Vitamin D3 (as cholecalciferol)…………….……. 20 mcg (800 IU)
dl-Alpha-Tocopheryl Acetate (as Vitamin E)……….....……. 30 mg
Thiamin (as thiamine mononitrate)…………...……………….3 mg
Riboflavin.....................…………………………...…...……. 3.4 mg
Niacin (as niacinamide)…………………………....………… 20 mg
Vitamin B6 (as pyridoxine hydrochloride)………….………..50 mg
Folate (as l-5-methyltetrahydrofolate calcium salt)……….. 1700 mcg DFE (1000 mcg L-5-Methylfolate)
Vitamin B12 (as cyanocobalamin)………………….……….10 mcg
Choline (as choline bitartrate)..............................................55 mg
Calcium (as calcium carbonate)……………………...……. 200 mg
Iron (as ferrous fumarate)...................................................27 mg
Iodine (as potassium iodide)............................................150 mcg
Magnesium (as magnesium oxide)……………………...….200 mg
Zinc (as zinc oxide)………………………………………....... 25 mg
Selenium (as selenium amino acid chelate)……………….70 mcg
Manganese (as manganese sulfate)………………………. 2.6 mg
Chromium (as chromium polynicotinate)………………..... 45 mcg
Molybdenum (as molybdenum amino acid chelate)……... 50 mcg
Other Ingredients:Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, clear coating (hydroxypropyl methylcellulose, polyethylene glycol 400).
INDICATIONS AND USAGE:
PNV Prenatol TM is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years.
PNV Prenatol TM may be beneficial in improving the nutritional status of women prior to conception.
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 B12 is deficient.
PRECAUTIONS:
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 neurological 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 neurological changes caused by pernicious anemia. The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.
Drug Interactions:
PNV Prenatol™ tablets are 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., heparin) and antiplatelet agents (e.g., aspirin 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 PNV Prenatol™ tablets after meals may control occasional gastrointestinal disturbances.
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.
For use on the order of a physician.
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.
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 excessive amounts of iron are ingested by children, severe reactions, including fatalities, have resulted. PNV Prenatol TM should be kept out of reach of children to prevent accidental iron poisoning.
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:
Take one (1) PNV Prenatol™ tablet daily, preferably between meals, or as directed by a physician. Do not use in children under 12 years of age.
HOW SUPPLIED:
PNV Prenatol™ tablets are light beige to beige, brown-speckled, oblong, film-coated tablets debossed with “PT A18” on one side. They are supplied in bottles of 30 tablets (NDC 59088-078-54).
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Avoid excessive heat.
Dispense in a tight, light-resistant container as defined in the USP/NF, with a child-resistant closure.
Do not use if the seal under the bottle cap is broken.
KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.