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  5. Label Information: Prenate Mini

FDA Label for Prenate Mini

View Indications, Usage & Precautions

Table of Contents

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

Prenate Mini 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 Prenatal 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.

Sumalate ® is a registered trademark of Albion Laboratories,Inc., covered by one or more claims of U.S. Patent Nos. 6,716,814; 8,007,846; and 8,425,956.

Ferronyl ® is a registered trademark of ISP Investments, Inc.

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. 1114


Description



DESCRIPTION: PRENATE MINI ® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each oval softgel is teal green in color and imprinted with “Mini”.


Dosage & Administration



Supplement Facts
Serving Size: 1 Softgel
Amount per Serving:% Daily
Value 		% Daily
Value
(Pregnant & Lactating Women)
Vitamin C
(as ascorbic acid) 		60 mg100%100%
Vitamin D 3
(as cholecalciferol) 		1000 IU250%250%
Vitamin E
(as dl-alpha tocopherol) 		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 carbonate) 		80 mg8%6%
Iron (as ferrous asparto glycinate) Sumalate ® and (carbonyl iron) - Ferronyl ®18 mg100%100%
Iodine
(as potassium iodide) 		150 mcg100%100%
Magnesium (as magnesium oxide)25 mg6%6%
Docosahexaenoic Acid
(DHA) 		350 mg

Daily Value (DV) not established.

Blueberry extract
(vaccinium spp.) 		25 mg

Contains fish oil and soy.

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


Inactive Ingredient



OTHER INGREDIENTS: Fish (tuna) oil, bovine gelatin, glycerin, soy lecithin, yellow beeswax, purified water, vegetable shortening, FD&C Blue #1, titanium dioxide and FD&C Yellow #5.


Indications & Usage



INDICATIONS: PRENATE MINI ® 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 MINI ® 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.

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 B12 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.


How Supplied



HOW SUPPLIED: Bottles of 30 softgels (75854-0315-30). 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 AND HANDLING SECTION: 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



75854-0315-30

Prenate mini

A small, easy-to-swallow
softgel with complete prenatal
nutrition support, including
350 mg of DHA

30 Softgels

Rx Only

Prenatal Supplement

GLUTEN FREE
LACTOSE FREE

Avion
PHARMACEUTICALS


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