Label: PRENATRIX- ferrous fumarate, folic acid tablet
- NDC Code(s): 59088-166-54
- Packager: PureTek Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated September 30, 2024
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DESCRIPTION:
Active ingredients:
Each caplet contains:Vitamin A (as retinyl acetate)………………………….. 1500 mcg
Vitamin C (as ascorbic acid)……………………………… 120 mg
Vitamin D3 (as cholecalciferol)…………………………… 20 mcg
Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg
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 selinium 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: BHT, dicalcium phosphate, croscarmellose sodium, crospovidone, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, modified food starch, pork gelatin, starch aluminium octenyl succinate, sodium ascorbate, sodium aluminum silicate, silicon dioxide, stearic acid, sucrose, Clear Coating: (hydroxypropyl methylcellulose, PEG-8). - Indications
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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 hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.
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BOXED WARNING
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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.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 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:
Prenatrix 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 Prenatrix after meals may control occasional gastrointestinal disturbances. Prenatrix 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.
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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,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. Prenatrix 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:
- Dosage and Administration:
- HOW SUPPLIED
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Storage
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 if bottle seal is broken.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
To report a serious adverse event or to obtain product information, contact 877-921-7873. - Prenatrix
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INGREDIENTS AND APPEARANCE
PRENATRIX
ferrous fumarate, folic acid tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59088-166 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 27 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 25 mg MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U) MOLYBDENUM 50 ug CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y) (CHOLINE - UNII:N91BDP6H0X) CHOLINE 55 mg CHROMIUM NICOTINATE (UNII: A150AY412V) (CHROMIC CATION - UNII:X1N4508KF1) CHROMIUM NICOTINATE 45 ug SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 70 ug POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE 150 ug MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 200 mg MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE CATION (2+) 2.6 mg VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 1500 ug ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 20 ug .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 30 mg THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 3 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3.4 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 50 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1000 ug CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 10 ug CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 200 mg Inactive Ingredients Ingredient Name Strength ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SUCROSE (UNII: C151H8M554) CROSPOVIDONE (UNII: 2S7830E561) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM) SODIUM ASCORBATE (UNII: S033EH8359) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) GELATIN (UNII: 2G86QN327L) Product Characteristics Color yellow ((Clear Coated Yellow to Brown speckled)) Score no score Shape CAPSULE ((Oblong Caplet)) Size 19mm Flavor Imprint Code PT;A18 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59088-166-54 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/29/2020 Labeler - PureTek Corporation (785961046)