Prenate Elite
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
PRENATAL VITAMINS-FILM COATED TABLETS
With
Quatrefolic®
Rx Only
DESCRIPTION: PRENATE ELITE® is a white, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with “PN” on one side and blank on the other.
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Supplement Facts
Serving Size: 1 Tablet |
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| Amount per Serving: | % Daily Value |
% Daily Value for Lactating Women |
|
| Vitamin A (100% as beta-carotene) | 2600 IU | 50% | 33% |
| Vitamin C (as ascorbic acid) | 75 mg | 125% | 125% |
| Vitamin D3 (as cholecalciferol) | 450 IU | 113% | 113% |
| Vitamin E (as dl-alpha tocopheryl acetate) | 10 IU | 33% | 33% |
| Thiamin (as thiamin mononitrate) | 3 mg | 200% | 176% |
| Riboflavin | 3.5 mg | 206% | 175% |
| Niacin (as niacinamide ) | 21 mg | 105% | 105% |
| Vitamin B6 (as pyridoxine HCl) | 21 mg | 1050% | 840% |
| Folate (as 1.1 mg Quatrefolic® ((6S)-5,methyltetrahydrofolate glucosamine salt* CAS 1181972-37-1) molar equivalent to 600 mcg of Folic Acid) (folic acid, USP 400 mcg) |
1 mg | 250% | 125% |
| Vitamin B12 (as cyanocobalamin) | 13 mcg | 217% | 163% |
| Biotin | 330 mcg | 110% | 110% |
| Pantothenic Acid (as calcium pantothenate) | 6 mg | 60% | 60% |
| Calcium (as calcium carbonate) | 100 mg | 10% | 8% |
| Iron (as ferrous fumarate) | 26 mg | 144% | 144% |
| Iodine (as potassium iodine) | 150 mcg | 100% | 100% |
| Magnesium (as magnesium oxide) | 25 mg | 6% | 6% |
| Zinc (as zinc oxide) | 15 mg | 100% | 100% |
| Copper (as copper oxide) | 1.5 mg | 75% | 75% |
OTHER INGREDIENTS: dicalcium phosphate, microcrystalline cellulose, stearic acid, aqueous coating, croscarmellose sodium, silica, magnesium stearate, titanium dioxide.
Uses
INDICATIONS: PRENATE ELITE® is a multivitamin/multimineral dietary 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.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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 0.1 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: PRENATE ELITE® is supplied in child-resistant bottles of 30 (75854-301-30) or child-resistant bottles of 90 tablets (75854-301-90).
The listed product number is not a National Drug Code, but has instead merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
MANUFACTURED FOR: Avion Pharmaceuticals, LLC
Atlanta, GA 30350
1-888-61-AVION
*Quatrefolic® is a registered trademark of Gnosis, SpA.Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1
PRENATE ELITE® is a registered trademark of Acella Pharmaceuticals, LLC.
Under license from Acella Pharmaceuticals, LLC.
All rights reserved.
Rev. 022012
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
75854-301-30 30 Tablets
Prenate Elite TM
PRENATAL VITAMINS-FILM-COATED TABLETS;
DHA®
with
Quatrefolic®
Prenate Elite.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, zinc oxide and cupric oxide TABLET, COATED
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