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  5. Label Information: Prenate Essential

FDA Label for Prenate Essential

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. DESCRIPTION
    3. INACTIVE INGREDIENT
    4. INDICATIONS & USAGE
    5. CONTRAINDICATIONS
    6. BOXED WARNING
    7. PRECAUTIONS
    8. ADVERSE REACTIONS
    9. DOSAGE & ADMINISTRATION
    10. HOW SUPPLIED
    11. STORAGE AND HANDLING
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prenate Essential Product Label

The following document was submitted to the FDA by the labeler of this product Avion Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Rx Only Dietary Supplement

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


Description



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
(Pregnant &
Lactating
Women)
Vitamin C (as ascorbic acid)90 mg150%150%
Vitamin D 3 (as cholecalciferol) 220 IU55%55%
Vitamin E (as dl-alpha tocopheryl acetate)10 IU33%33%
Vitamin B 6 (as pyridoxine HCl) 26 mg1300%1040%
Folate (as ((6S)-N5-methyltetrahydrofolic acid calcium salt (molar equivalent to 600 mcg of folic acid) and folic acid, USP 400 mcg)1 mg250%125%
Vitamin B 12 (as cyanocobalamin) 13 mcg217%163%
Biotin280 mcg93%93%
Calcium (as calcium formate) Formical ®155 mg16%12%
Iron (as ferrous asparto glycinate) Sumalate ®18 mg100%100%
Iodine (as potassium iodine)150 mcg100%100%
Magnesium (as magnesium oxide)50 mg13%11%
Docosahexaenoic acid (DHA)300 mg

Daily Value (DV) not established.

Eicosapentaenoic acid (EPA)40 mg

PRENATE ESSENTIAL ® contains fish oil and soy.


Inactive Ingredient



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 & Usage



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



CONTRAINDICATIONS: PRENATE ESSENTIAL ® is contraindicated in patients with a known hypersensitivity to any of the ingredients.


Boxed Warning



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.

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.


Precautions



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.


Adverse Reactions



ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.


Dosage & Administration



DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.


How Supplied



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 And Handling



STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]


Package Label.Principal Display Panel



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


* Please review the disclaimer below.