ascorbic acid, cholecalciferol, alpha-tocopherol, pyridoxine, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent
Dosage Form: capsule, gelatin coated
Prenate® Essential™
Rx prenatal vitamin & DHA
Prenate Essential Description
Prenate Essential™ is a prescription prenatal/postnatal multivitamin/mineral/ essential fatty acid softgel. Each softgel is blue-green in color, opaque, and imprinted with "Prenate" on one side.
| Percent Daily Values are based on a 2,000 calorie diet | |||
| |||
| Supplement Facts | |||
| Serving Size 1 Softgel | |||
| Amount Per Serving: | % DV For Adults | % DV for Pregnant and Lactating Women | |
| Vitamin C | 85 mg | 142% | 142% |
| Vitamin D3 | 200 IU | 50% | 50% |
| Vitamin E | 10 IU | 33% | 33% |
| Vitamin B6 | 25 mg | 1250% | 1000% |
| Folate | 1 mg | 250% | 125% |
| (L-methylfolate as Metafolin 600 mcg) (folic acid, USP 400mcg) | |||
| Vitamin B12 | 12 mcg | 200% | 150% |
| Biotin | 300 mcg | 100% | 100% |
| Calcium (calcium carbonate) | 140 mg | 14% | 11% |
| Iron (ferrous fumarate) | 28 mg | 156% | 156% |
| Iodine (potassium iodide) | 150 mcg | 100% | 100% |
| Magnesium (magnesium oxide) | 45 mg | 11% | 10% |
| Docosahexaenoic Acid (DHA) | 300 mg | * | * |
| Eicosapentaenoic Acid (EPA) | 40mg | * | * |
| (from 340 mg omega-3 fatty acids from fish oil) | |||
Other Ingredients: fish oil, gelatin, hydrogenated vegetable oil, glycerin, sorbitol, beeswax, soy lecithin, titanium dioxide, vanillin, FD&C blue No. 1, propylene glycol, hypromellose.
INDICATIONS
Prenate Essential is a multivitamin/mineral/essential fatty acid nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating 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 Ratio (INR). Administsration 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.
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 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.
Prenate Essential Dosage and Administration
Before, during, and/or after pregnancy, one softgel daily or as directed by a physician.
How is Prenate Essential Supplied
Unit-dose packs of 30 softgels
- NDC # 59630-419-30
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]
For inquiries call 1-800-849-9707 extension 1454.
PNE-BC3-1
Rev. 01/10
U.S. Patents #5,997,915; # ,254,904; #6,011,040; #6,451,360; #6,673,381; #6,808,725; #6,441,168
Prenate Essential® is a registered trademark of Shionogi Pharma, Inc. Metafolin® is a registered trademark of Merck KGaA, Darmstadt Germany. ©2010 Shionogi Pharma, Inc.
Atlanta, GA
All rights reserved.
Manufactured for:
SHIONOGI PHARMA, INC.
Atlanta, Georgia USA 30328 Manufactured by:
Catalent Pharma Solutions, Swindon, UK.
Made in the United Kingdom
Prenate® Essential™
Rx prenatal vitamin & DHA
With
META FOLIN®
PRINCIPAL DISPLAY PANEL - 30 Softgel Carton
NDC-59630-419-30
30 Softgels
Prenate® Essential™
Rx prenatal vitamin & DHA
- Key vitamins, minerals, and DHA support nutrition
With
META FOLIN®
Rx Only
US 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, Darmstadt Germany
©2010 Shionogi Pharma, Inc. Atlanta, GA
All rights reserved.
| Prenate Essential ascorbic acid, cholecalciferol, alpha-tocopherol, pyridoxine, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent, and icosapent capsule, gelatin coated | |||||||||||||||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| UNAPPROVED DRUG OTHER | 03/30/2010 | ||
| Labeler - Sciele Pharma, Inc. (802728477) |
More Prenate Essential resources
- Prenate Essential Side Effects (in more detail)
- Prenate Essential Use in Pregnancy & Breastfeeding
- Prenate Essential Drug Interactions
- 0 Reviews for Prenate Essential - Add your own review/rating
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