vitamin a, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cyanocobalamin, biotin, pantothenic acid, calcium carbonate, ferrous fumarate, iodine, magnesium, zinc and copper
Dosage Form: tablet, film coated
Prenate Elite® Tablets Rx
Prenate Elite Description
Prenate Elite® is a white oval oil- and water-soluble multivitamin/multimineral film-coated tablet debossed with "PN" on one side.
| * Percent Daily Values (DV) are based on a 2,000 calorie diet | |||
| Supplement Facts | |||
| Serving Size 1 Tablet | |||
| Amount Per Serving | % DV | % DV for Pregnant and Lactating Women | |
| Vitamin A (100% as Beta-Carotene) | 2500 IU | 50 % | 31 % |
| Vitamin C | 80 mg | 133 % | 133 % |
| Vitamin D3 | 400 IU | 100 % | 100 % |
| Vitamin E | 10 IU | 33 % | 33 % |
| Thiamin (Vitamin B1) | 3 mg | 200 % | 176 % |
| Riboflavin (Vitamin B2) | 3.4 mg | 200 % | 170 % |
| Niacinamide | 20 mg | 100 % | 100 % |
| Vitamin B6 | 20 mg | 1000 % | 800 % |
| Folate | 1 mg | 250 % | 125 % |
| (L-methylfolate calcium 676 mcg (as Metafolin®) molar equivalent to 600 mcg of Folic Acid) | |||
| (Folic acid, USP 400 mcg) | |||
| Vitamin B12 | 12 mcg | 200 % | 150 % |
| Biotin | 300 mcg | 100 % | 100 % |
| Pantothenic acid | 6 mg | 60 % | 60 % |
| Calcium (calcium carbonate) | 120 mg | 12 % | 9 % |
| Iron (ferrous fumarate) | 27 mg | 150 % | 150 % |
| Iodine | 150 mcg | 100 % | 100 % |
| Magnesium | 30 mg | 8 % | 7 % |
| Zinc | 15 mg | 100 % | 100 % |
| Copper | 2 mg | 100 % | 100 % |
Other Ingredients: ascorbyl palmitate, calcium sulfate, croscarmellose sodium, dicalcium phosphate, gelatin, hydrogenated soybean oil, hydrogenated vegetable oil, hypromellose, magnesium stearate, maltodextrin, medium chain triglycerides, microcrystalline cellulose, mono and diglycerides, partially hydrogenated soybean oil, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, sodium aluminum silicate, sodium ascorbate, starch, stearic acid, sucrose, talc, titanium dioxide, and water.
Metafolin® (L-methylfolate calcium) is a substantially diastereoisomerically pure source of L-methylfolate containing not more than 1% D-methylfolate.
INDICATIONS
Prenate Elite® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Prenate Elite® can also be beneficial in improving the nutritional status of women prior to conception.
Contraindications
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.
Precautions
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Adverse Reactions
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Prenate Elite Dosage and Administration
One tablet daily or as directed by a physician.
How is Prenate Elite Supplied
Child-resistant bottles of 90 tablets – NDC 59630-416-90
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].
U.S. Patents #5,997,915; #6,011,040; #6,254,904; #6,441,168; #6,451,360; #6,673,381; #6,808,725
Prenate Elite® is a registered trademark of Shionogi Pharma, Inc. Metafolin® is a registered
trademark of Merck KGaA, Darmstadt, Germany.
©2010 Shionogi Pharma, Inc. Atlanta, GA.
All rights reserved.
Manufactured for:
SHIONOGI PHARMA, INC.
Atlanta, GA 30328
Manufactured by:
Pharmetics, Inc.
Laval, Quebec H7L 3H7
Made in Canada
To report a serious adverse event or obtain product information,
contact 1-800-849-9707 ext. 1454
PNI-PI-3
Rev. 02/10
PRINCIPAL DISPLAY PANEL - 90 Tablets Bottle Label
NDC 59630-416-90
Prenate Elite®
PRENATAL VITAMINS—FILM-COATED TABLETS
With
METAFOLIN®
90 Tablets
Rx Only
Manufactured for:
SHIONOGI PHARMA, INC.
Atlanta, GA 30328
Manufactured by:
Pharmetics Inc.
Laval, Quebec H7L 3H7
Made in Canada
PNI-TL-2
Rev. 02/10
8633-1
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| UNAPPROVED DRUG OTHER | 09/01/2008 | ||
| Labeler - Shionogi Pharma, Inc. (802728477) |
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