PRENATE ELITE - 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
tablet, film coated
Shionogi Pharma, Inc.

DESCRIPTION
PRENATE ELITE® is a white oval oil- and water-soluble multivitamin/multimineral film-coated tablet debossed with "PN" on one
side.
Supplement Facts
Serving Size 1 Tablet
% DV for Pregnant
Amount Per Serving % DV and Lactating Women
Vitamin A 2500 IU 50 % 31 %
(100% as Beta-Carotene)
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 %
* Percent Daily Values (DV) are based on a 2,000 calorie diet

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.

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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.

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.

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

HOW 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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