Prenatryl, Prometa FERROUS FUMARATE FOLIC ACID PURETEK CORPORATION FDA Approved Full Prescribing Information: Active ingredient: 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)…………………. 50 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) 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 iodine)…………………………….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, PEG-8).

PRENATRYL

(+1 other brands)
Mfr: PURETEK CORPORATION FDA Rx Only

Drug Facts

Composition & Profile

Treats Conditions
Indications 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 May Be Beneficial In Improving The Nutritional Status Of Women Prior To Conception
Pill Appearance
Shape: capsule Color: brown

Identifiers & Packaging

Container Type BOTTLE
UPC
0359088169544
UNII
25X51I8RD4 6K2W7T9V6Y 3LE3D9D6OY P6YC3EG204 1C6V77QF41 SOI2LOH54Z 8K0I04919X R5L488RY0Q PQ6CK8PD0R H0G9379FGK 68Y4CF58BV WR1WPI7EW8 1C4QK22F9J W00LYS4T26 81AH48963U 935E97BOY8 3A3U0GI71G H6241UJ22B TLM2976OFR A150AY412V
Packaging

HOW SUPPLIED Prometa ™ 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 child-resistant closure. Prenatryl™ are beige speckled, oblong, coated caplets in bottles containing 30 caplets – NDC 59088-169-54. 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.; Prometa™ Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 Questions? Call toll-free: 1-877-921-7873 Label2; Prenatryl​™ Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 Questions? Call toll-free: 1-877-921-7873 Label

Package Descriptions
  • HOW SUPPLIED Prometa ™ 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 child-resistant closure. Prenatryl™ are beige speckled, oblong, coated caplets in bottles containing 30 caplets – NDC 59088-169-54. 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.
  • Prometa™ Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 Questions? Call toll-free: 1-877-921-7873 Label2
  • Prenatryl​™ Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 Questions? Call toll-free: 1-877-921-7873 Label

Overview

Full Prescribing Information: Active ingredient: 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)…………………. 50 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) 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 iodine)…………………………….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, PEG-8).

Indications & Usage

Indications 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. May be beneficial in improving the nutritional status of women prior to conception.

Dosage & 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.

Warnings & Precautions
No warnings available yet.
Boxed 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.
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.

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 after meals may control occasional gastrointestinal disturbances. It 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.

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 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 after meals may control occasional gastrointestinal disturbances. It 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.

Storage & Handling

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 1-877-921-7873.


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