New Prenate Elite® PI Old Prenate Elite® PI
DESCRIPTION: PRENATE ELITE® is a white oval oil- and water-soluble multivitamin/multimineral film-coated tablet debossed with “PN” on one side DESCRIPTION: PRENATE ELITE® is a white oval oil- and water-soluble multivitamin/multimineral film-coated tablet debossed with "PN" on one side.
Each tablet contains:
Vitamin A (100% as beta-carotene)......................2500 IU
Vitamin C (ascorbic acid)........................................80 mg
Vitamin D3 (cholecalciferol)........................................400 IU
Vitamin E (dl-alpha tocopherol acetate)....................10 IU
Vitamin B1 (thiamine mononitrate) ............................3 mg
Vitamin B2 (riboflavin)..................................................3.4 mg
Niacinamide..................................................................20 mg
Vitamin B6 (pyridoxine HCl)........................................20 mg
Folate...... ......................................................................1 mg
(L-methylfolate as Metafolin® 600 mcg)
(folic acid, USP 400 mcg)
Vitamin B12....................................................................12 mcg
Biotin.............................................................................300 mcg
Pantothenic acid (calcium pantothenate)...................6 mg
Calcium (calcium carbonate)..................................120 mg
Iron (ferrous fumarate)..............................................27 mg
Iodine (potassium iodide)........................................150 mcg
Magnesium (magnesium oxide)..................................30 mg
Zinc (zinc oxide)............................................................15 mg
Copper (copper oxide).................................................2 mg

Other Ingredients: ascorbyl palmitate, calcium sulfate, croscarmellose sodium, dicalcium phosphate, gelatin, hydrogenated soybean oil, hydrogenated vegetable oil, porcine gelatin, 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.

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.
Each tablet contains:
Elemental Iron (carbonyl iron).......................................90 mg
Biotin ...................................................................................30 mcg
Pantothenic acid (calcium pantothenate, USP)................6 mg
Calcium (calcium carbonate, USP)...............................200 mg
Copper (cupric oxide) .........................................................2 mg
Zinc (zinc oxide, USP) .........................................................15 mg
Folate ....................................................................................1 mg
(L-methylfolate as Metafolin® 600 mcg)
(folic acid, USP 400 mcg)
Vitamin D3 (cholecalciferol) ................................................400 IU
Vitamin E (dl-alpha tocopheryl acetate) ............................10 IU
Vitamin C (ascorbic acid, USP) ......................................120 mg
Vitamin B1 (thiamine mononitrate)......................................3 mg
Vitamin B2 (riboflavin, USP) ................................................3.4 mg
Vitamin B6 (pyridoxine HCl) ................................................20 mg
Vitamin B12 (cyanocobalamin) ...........................................12 mcg
Niacinamide, USP................................................................20 mg
Magnesium (magnesium oxide, USP) ..............................30 mg
Docusate Sodium, USP ..................................................50 mg

Other Ingredients: calcium phosphate dibasic, carnauba wax, crospovidone, dextrin, dl-alpha tocopherol, hypromellose, lactose, magnesium stearate, mono and diglycerides, polacrilin, pregelatinized starch, propylene glycol, silicon dioxide, sodium benzoate, partially hydrogenated soybean oil, starch, stearic acid, sucrose, and titanium dioxide.

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.
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.
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 Sciele Pharma, Inc. Metafolin® is a registered trademark of Merck KGaA, Germany.

Manufactured for:
Sciele Pharma, Inc.
Atlanta, GA 30328

Manufactured by:
Pharmetics, Inc.
Laval, Quebec H7L 3H7
Made in Canada

For inquiries call 1-800-849-9707 ext. 1454

PNI-PI-1 Rev. 08/08
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 unit-dose packs of 90 tablets - NDC 59630-411-90
KEEP THIS AND ALL DRUGS OUT OF THE 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]

Manufactured for:
Sciele Pharma, Inc.
Atlanta, GA 30328

Manufactured by:
Patheon Inc.
Fort Erie, ON L2A 2S9
Made in Canada

For inquiries call 1-800-849-9707

PNE-PI-2 Rev. 11/06

U.S. Patents #5,997,915, #6,254,904, #6,011,040, #6,451,360, #6,673,381, #6,808,725, #6,441,168.
Metafolin® is a registered trademark of Merck KGaA, Germany.

Kosher Certified