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 
Avion Pharmaceuticals, LLC

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.

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PRENATE MINI

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.

*
Daily Value (DV) not established.
Supplement Facts
Serving Size: 1 Softgel
Amount per Serving:% Daily Value% Daily Value for
Lactating Women
Vitamin C (as ascorbic acid)60 mg100%100%
Vitamin D 3 (as cholecalciferol) 220 IU55%55%
Vitamin E (as dl-alpha tocopherol)10 IU33%33%
Vitamin B 6 (as pyridoxine HCl) 26 mg1300%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 mg250%125%
Vitamin B 12 (as cyanocobalamin) 13 mcg217%163%
Biotin280 mcg93%93%
Calcium (as calcium carbonate)100 mg10%8%
Iron (as iron carbonyl)29 mg161%161%
Iodine (as potassium iodide)150 mcg100%100%
Magnesium (as magnesium oxide)25 mg6%6%
Docosahexaenoic Acid (DHA)350 mg**
Blueberry Extract (vaccinium angustifolium)25 mg**

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.

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

PRINCIPAL DISPLAY PANEL - 30 tablets
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:75854-304
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL220 [iU]
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-10 [iU]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE26 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN13 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN280 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION100 mg
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION29 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION150 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE25 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT350 mg
LOWBUSH BLUEBERRY (UNII: G90PX41VP0) (ICOSAPENT - UNII:AAN7QOV9EA) LOWBUSH BLUEBERRY25 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
Inactive Ingredients
Ingredient NameStrength
FISH OIL (UNII: XGF7L72M0F)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CORN OIL (UNII: 8470G57WFM)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TURMERIC (UNII: 856YO1Z64F)  
Product Characteristics
ColoryellowScore2 pieces
ShapeOVALSize24mm
FlavorImprint Code mini
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75854-304-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/15/201209/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/15/201209/30/2016
Labeler - Avion Pharmaceuticals, LLC (965450542)
Establishment
NameAddressID/FEIBusiness Operations
Avion Pharmaceuticals, LLC965450542manufacture(75854-304)

Revised: 1/2018
 
Avion Pharmaceuticals, LLC