Prenate Elite
Generic Name: multivitamin/multimineral
Dosage Form: tablet, coated
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.
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Rx Only Dietary Supplement
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.
| Supplement Facts Serving Size: 1 Tablet |
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| Amount per Serving: | % Daily Value | % Daily Value (Pregnant & Lactating Women |
|
| Vitamin A (100% as beta-carotene) | 2600 IU | 52% | 33% |
| Vitamin C (as ascorbic acid) | 75 mg | 125% | 125% |
| Vitamin D 3 (as cholecalciferol) | 600 IU | 150% | 150% |
| Vitamin E (as dl-alpha tocopheryl acetate) | 40 IU | 133% | 133% |
| Thiamin (as thiamine mononitrate) | 3 mg | 200% | 176% |
| Riboflavin | 3.5 mg | 206% | 175% |
| Niacinamide | 21 mg | 105% | 105% |
| Vitamin B 6 (as pyridoxine HCl) | 21 mg | 1050% | 840% |
| Folate (as 1.11 mg of ((6S)-N5-methyltetrahydrofolic acid calcium salt (molar equivalent to 600 mcg of folic acid) and folic acid, USP 400 mcg) |
1 mg | 250% | 125% |
| Calcium (as calcium formate) Formical ® | 155 mg | 16% | 12% |
| Iron (as ferrous asparto glycinate) Sumalate ® | 20 mg | 111% | 111% |
| Vitamin B 12 (as cyanocobalamin) | 13 mcg | 217% | 163% |
| Biotin | 330 mcg | 110% | 110% |
| Iodine (as potassium iodide) | 150 mcg | 100% | 100% |
| Magnesium (as magnesium oxide) | 25 mg | 6% | 6% |
| Zinc (as zinc oxide) | 15 mg | 100% | 100% |
| Copper (as cupric oxide) | 1.5 mg | 75% | 75% |
OTHER INGREDIENTS: Cellulose, Silicon Dioxide, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Film Coating (Hydro Propyl Methyl Cellulose, Triacetin, Titanium Dioxide).
INDICATIONS: Prenate Elite ® is a multivitamin/multimineral fatty acid 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.
CONTRAINDICATIONS: Prenate Elite ® is contraindicated in patients with a known hypersensitivity to any of the ingredients.
PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 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.
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.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one tablet daily or as directed by a physician.
HOW SUPPLIED: Bottles of 30 tablets (75854-314-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.
STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Formical ® is a registered trademark of Nephro-Tech 1, LLC, covered by one or more claims of U.S. Patent No. 6,528,542.
Sumalate ® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956.
PRENATE ® is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.
MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30022
1-888-61-AVION
Rev. 0614
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
75854-314-30
Prenate Elite ®
PRENATAL VITAMINS-FILM-COATED TABLETS
GLUTEN FREE
Rx Only
Dietary Supplement
30 Tablets
AVION
PHARMACEUTICALS
| Prenate Elite .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, calcium formate, ferrous asparto glycinate, cyanocobalamin, biotin, potassium iodide, magnesium oxide, zinc oxide and cupric oxide tablet, coated |
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| Labeler - Avion Pharmaceuticals, LLC (965450542) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Avion Pharmaceuticals, LLC | 965450542 | manufacture(75854-314) | |
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