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PRENATE ESSENTIAL | Prenate Essential [Avion Pharmaceuticals, LLC] | BioPortfolio

13:17 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Rx Only Dietary Supplement

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.

PRENATE ESSENTIAL contains fish oil and soy.

Supplement Facts
Serving Size: 1 Softgel
Amount per Serving: % Daily Value % Daily
Value
(Pregnant &
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 acetate) 10 IU 33% 33%
Vitamin B 6 (as pyridoxine HCl) 26 mg 1300% 1040%
Folate (as ((6S)-N5-methyltetrahydrofolic acid calcium salt (molar equivalent to 600 mcg of folic acid) and 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 formate) Formical ® 155 mg 16% 12%
Iron (as ferrous asparto glycinate) Sumalate ® 18 mg 100% 100%
Iodine (as potassium iodine) 150 mcg 100% 100%
Magnesium (as magnesium oxide) 50 mg 13% 11%
Docosahexaenoic acid (DHA) 300 mg Daily Value (DV) not established.
Eicosapentaenoic acid (EPA) 40 mg

OTHER INGREDIENTS: Bovine gelatin, glycerin, soy lecithin, white beeswax, purified water, soybean oil, 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.

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). 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 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 softgel daily or as directed by a physician.

HOW SUPPLIED: Bottles of 30 softgels (75854-313-30). 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

75854-313-30

PRENATE ESSENTIAL Rx prenatal vitamin & DHA Essential

• Key vitamins, minerals, and DHA support nutrition

GLUTEN FREE Rx Only Dietary Supplement

30 Softgels

AVION PHARMACEUTICALS

Manufacturer

Avion Pharmaceuticals, LLC

Active Ingredients

Source

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