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prenate mini

Avion Pharmaceuticals, LLC


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

A complete Rx prenatal vitamin that's easy to swallow

With
Quatrefolic

Rx Only

DESCRIPTION: PRENATE MINI is a yellow, oval multivitamin/multimineral softgel imprinted with “mini” on one side and blank on the other.

Supplement Facts
Serving Size: 1 Softgel
Amount per Serving: % Daily Value % Daily Value for
Lactating Women
Vitamin C (as ascorbic acid) 60 mg 100% 100%
Vitamin D3 (as cholecalciferol) 220 IU 55% 55%
Vitamin E (as dl-alpha tocopherol) 10 IU 33% 33%
Vitamin B6 (as pyridoxine HCl) 26 mg 1300% 1040%
Folate
(as 1.1 mg Quatrefolic® ((6S)-5,methyltetrahydrofolate glucosamine salt* CAS 1181972-37-1) molar equivalent to 600 mcg of Folic Acid) (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) 100 mg 10% 8%
Iron (as iron carbonyl) 29 mg 161% 161%
Iodine (as potassium iodide) 150 mcg 100% 100%
Magnesium (as magnesium oxide) 25 mg 6% 6%
Docosahexaenoic Acid (DHA) 350 mg Daily Value (DV) not established. Daily Value (DV) not established.
Blueberry Extract (vaccinium angustifolium) 25 mg Daily Value (DV) not established. Daily Value (DV) not established.

PRENATE MINI contains fish oil and soy.

OTHER INGREDIENTS: fish oil, gelatin, glycerin, purified water, beeswax, soy lecithin, hydrogenated vegetable oil, titanium dioxide, and tumeric powder.

Uses

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.

PRENATE MINI can also be beneficial in improving the nutritional status of women prior to conception.

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.

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 0.1 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: PRENATE MINI is supplied in child-resistent bottles of 30 softgels. (75854-304-30).

The listed product number is not a National Drug Code, but has instead merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

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

MANUFACTURED FOR: Avion Pharmaceuticals, LLC
Atlanta, GA 30350
1-888-61-AVION

*Quatrefolic® is a registered trademark of Gnosis, SpA.Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1

PRENATE MINI is a registered trademark of Acella Pharmaceuticals, LLC.
Under license from Acella Pharmaceuticals, LLC.
All rights reserved.

Rev. 0612

To learn more about your pregnancy, go to www.PrenatePERL.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-304-30

30 Softgels

Rx Only

PRENATE MINI
A complete Rx prenatal vitamin that’s easy to swallow

With
Quatrefolic®

Manufactured For:
Avion
PHARMACEUTICALS
Atlanta, GA 30350

Prenate Mini is a trademark of Acella Pharmaceuticals, LLC.
*Quatrefolic® is a registered trademark of Gnosis, SpA.
Under license from Acella Pharmaceuticals LLC
All rights reserved.

Rev. 0412

prenate mini

prenate mini

ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, iron pentacarbonyl, potassium iodide, magnesium oxide, doconexent and lowbush blueberry CAPSULE, GELATIN COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:75854-304
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ASCORBIC ACID ASCORBIC ACID 60 mg
CHOLECALCIFEROL CHOLECALCIFEROL 220 [iU]
.ALPHA.-TOCOPHEROL, DL- 10 [iU]
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 26 mg
FOLIC ACID FOLIC ACID 1 mg
Cyanocobalamin CYANOCOBALAMIN 13 ug
BIOTIN 280 ug
CALCIUM CARBONATE 100 mg
IRON PENTACARBONYL FERROUS CATION 29 mg
Potassium Iodide IODIDE ION 150 ug
magnesium oxide 25 mg
DOCONEXENT DOCONEXENT 350 mg
LOWBUSH BLUEBERRY 25 mg

Inactive Ingredients

Ingredient Name Strength
FISH OIL
GELATIN
GLYCERIN
water
YELLOW WAX
LECITHIN, SOYBEAN
CORN OIL
titanium dioxide
TURMERIC

Product Characteristics

Color Size Imprint Code Shape
YELLOW 24 mm mini OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:75854-304-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-05-15


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