PROMETA- ferrous fumarate, folic acid tablet

Prometa by

Drug Labeling and Warnings

Prometa by is a Prescription medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION:

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 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

Prometa 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.



Prometa 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 folic acid may obscure its signs and symptoms.

BOXED WARNING

(What is this?)

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:

Prometa 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.

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. Prometa 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) Prometa caplet



daily, between meals or as directed by a physician. Do not administer to children under the age



of 12.

HOW SUPPLIED

Prometa are beige speckled, oblong, coated caplets, 30 caplets – NDC: 59088-172-54. 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.

Prometa

Manufactured by:



PureTek Corporation



Panorama City, CA 91402



For questions or information



call toll-free: 877-921-7873

INGREDIENTS AND APPEARANCE

PROMETA 
ferrous fumarate, folic acid tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 59088-172
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
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
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	70 ug
CHROMIUM NICOTINATE (UNII: A150AY412V) (CHROMIC CATION - UNII:X1N4508KF1)	CHROMIUM NICOTINATE	45 ug
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	POTASSIUM IODIDE	150 ug

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSPOVIDONE (UNII: 2S7830E561)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	brown (beige speckled caplets)	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-172-54	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/11/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/11/2021

Labeler - PureTek Corporation (785961046)

Establishment
Name	Address	ID/FEI	Business Operations
PureTek Corporation		785961046	label(59088-172) , manufacture(59088-172) , pack(59088-172) , relabel(59088-172)