Label: PROMETA- ferrous fumarate, folic acid tablet
PRENATRYL- ferrous fumarate, folic acid tablet
- NDC Code(s): 59088-169-54, 59088-172-54
- Packager: PureTek Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated October 8, 2024
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DESCRIPTION:Full Prescribing Information: Active ingredient: Each caplet contains: Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU) Vitamin C (as ascorbic acid)……………………………… 120 mg ...
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IndicationsIndicated 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. May ...
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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 ...
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BOXED WARNING
(What is this?)Precautions - 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 ...
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 B 12 is deficient.
Precautions
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 B 12 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.
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Drug Interactions: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 ...
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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 ...
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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 ...
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Dosage and Administration:Adults (persons over 12 years of age) One (1) caplet daily, between meals, or as directed by a physician. Do not administer to children under the age of 12.
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HOW SUPPLIEDPrometa™ are beige speckled, oblong, coated caplets in bottles containing 30 caplets – NDC 59088-172-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a ...
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StorageDo 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 ...
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Prometa™
Manufactured in the USA by: PureTek Corporation - Panorama City, CA 91402 - Questions? Call toll-free: 1-877-921-7873
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Prenatryl™
Manufactured in the USA by: PureTek Corporation - Panorama City, CA 91402 - Questions? Call toll-free: 1-877-921-7873
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INGREDIENTS AND APPEARANCEProduct Information