prenate essential
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Rx prenatal vitamin & DHA
With
Quatrefolic®
Rx Only
DESCRIPTION: PRENATE ESSENTIAL® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is green in color, opaque, and imprinted with 'Prenate' on one side and blank on the other.
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Supplement Facts
Serving Size: 1 Softgel |
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| Amount per Serving: | % Daily Value |
% Daily Value for Lactating Women |
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| Vitamin C (as ascorbic acid) | 90 mg | 150% | 150% |
| Vitamin D3 (as cholecalciferol) | 220 IU | 55% | 55% |
| Vitamin E (as dl-alpha tocopheryl) | 10 IU | 33% | 33% |
| Vitamin B6 (as pyridoxine HCl) | 26 mg | 1300% | 1040% |
| 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 | 280 mcg | 93% | 93% |
| Calcium (as calcium carbonate) | 145 mg | 15% | 11% |
| Iron (as ferrous fumarate) | 29 mg | 161% | 161% |
| Iodine (as potassium iodine) | 150 mcg | 100% | 100% |
| Magnesium (as magnesium oxide) | 50 mg | 13% | 11% |
| Docosahexaenoic Acid (DHA) | 300 mg |
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| Eicosapentaenoic Acid (EPA) | 40 mg |
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PRENATE ESSENTIAL® contains fish oil and soy.
OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, soy lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Yellow #5, FD&C Blue #1 and FD&C Yellow #6.
Uses
INDICATIONS: PRENATE ESSENTIAL® 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.
PRENATE ESSENTIAL® can also be beneficial in improving the nutritional status of women prior to conception.
CONTRAINDICATIONS: PRENATE ESSENTIAL® is contraindicated in patients with a known hypersensitivity to any of the ingredients
WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ration (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.
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.
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 softgel daily or as directed by a physician.
HOW SUPPLIED: Unit-dose packs of 30 softgels. (75854-303-30).
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 ESSENTIAL® is a registered trademark of Acella Pharmaceuticals, LLC.
Under license from Acella Pharmaceuticals, LLC.
All rights reserved.
Rev. 021412
To learn more about your pregnancy, go to www.PrenatePERL.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
75854-303-30 30 Softgels
PRENATE ESSENTIAL®
Rx prenatal vitamin & DHA
Essential®
with
Quatrefolic®
• Key vitamins, minerals, and DHA support nutrition
Long lasting stability
Improved bioavailability
High water solubility
Established safety
Quatrefolic® Rx Only
Prenate DHA is a registered trademark of Acella Pharmaceuticals, LLC.
*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
Under license from Acella Pharmaceuticals, LLC.
All rights reserved.
prenate essential- ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent TABLET, COATED
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