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
Avion Pharmaceuticals, LLC
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
----------
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.
|
|||
Supplement Facts
Serving Size: 1 Softgel | |||
Amount per Serving: | % Daily Value | % Daily Value for
Lactating Women |
|
Vitamin C (as ascorbic acid) | 90 mg | 150% | 150% |
Vitamin D 3 (as cholecalciferol) | 220 IU | 55% | 55% |
Vitamin E (as dl-alpha tocopheryl) | 10 IU | 33% | 33% |
Vitamin B 6 (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 B 12 (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 | * | * |
Eicosapentaenoic Acid (EPA) | 40 mg | * | * |
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.
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 B 12 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
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 |
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
Labeler - Avion Pharmaceuticals, LLC (040348516) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Avion Pharmaceuticals, LLC | 965450542 | manufacture(75854-303) |