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Prenate Mini

Generic Name: ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, iron pentacarbonyl, potassium iodide, magnesium oxide, doconexent and lowbush blueberry
Dosage Form: capsule, gelatin coated

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.

Prenate Mini® 75854-0315-30

Rx Only Prenatal Supplement

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”.

*
Daily Value (DV) not established.
Supplement Facts
Serving Size: 1 Softgel
   
Amount per Serving: % Daily
Value
% Daily
Value
(Pregnant & Lactating Women)
Vitamin C
(as ascorbic acid)
60 mg 100% 100%
Vitamin D3
(as cholecalciferol)
1000 IU 250% 250%
Vitamin E
(as dl-alpha tocopherol)
10 IU 33% 33%
Vitamin B6
(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 B12 (as cyanocobalamin) 13 mcg 217% 163%
Biotin 280 mcg 93% 93%
Calcium
(as calcium carbonate)
80 mg 8% 6%
Iron (as ferrous asparto glycinate) Sumalate® and (carbonyl iron) - Ferronyl® 18 mg 100% 100%
Iodine
(as potassium iodide)
150 mcg 100% 100%
Magnesium (as magnesium oxide) 25 mg 6% 6%
Docosahexaenoic Acid
(DHA)
350 mg * *
Blueberry extract
(vaccinium spp.)
25 mg * *

Contains fish oil and soy.

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: 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: Prenate Mini® 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.

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 1.0 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.

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

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

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

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

Prenate Mini 
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous asparto glycinate, iron, potassium iodide, magnesium oxide, doconexent and lowbush blueberry capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-315
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 1000 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 10 [iU]
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 26 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 400 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 13 ug
BIOTIN (BIOTIN) BIOTIN 280 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 80 mg
FERROUS ASPARTO GLYCINATE (FERROUS CATION) FERROUS CATION 9 mg
IRON (IRON) IRON 9 mg
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 150 ug
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 25 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 350 mg
LOWBUSH BLUEBERRY (ICOSAPENT) LOWBUSH BLUEBERRY 25 mg
LEVOMEFOLIC ACID (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 600 ug
Inactive Ingredients
Ingredient Name Strength
FISH OIL  
GELATIN  
GLYCERIN  
LECITHIN, SOYBEAN  
YELLOW WAX  
WATER  
CORN OIL  
FD&C BLUE NO. 1  
TITANIUM DIOXIDE  
FD&C YELLOW NO. 5  
Product Characteristics
Color GREEN (teal green) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code Mini
Contains         
Packaging
# Item Code Package Description
1 NDC:75854-315-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 11/18/2014
Labeler - Avion Pharmaceuticals, LLC (965450542)
Revised: 04/2015
 
Avion Pharmaceuticals, LLC



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