PROMETA- ferrous fumarate, folic acid tablet PRENATRYL- ferrous fumarate, folic acid tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838), MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457), VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01), THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMIN

Available from:

PureTek Corporation

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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. 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.

Product summary:

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.

Authorization status:

unapproved drug other

Summary of Product characteristics

PROMETA- FERROUS FUMARATE, FOLIC ACID TABLET
PRENATRYL- FERROUS FUMARATE, FOLIC ACID TABLET
PURETEK CORPORATION
_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._
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PROMETA & PRENATRYL
DESCRIPTION:
FULL PRESCRIBING INFORMATION:
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
Indicated to provide vitamins and minerals to women throughou