PRENATE PIXIE- ascorbic acid, biotin, cholecalciferol, cyanocobalamin, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, docusate sodium and blueberry tablet, film coated

Prenate Pixie by

Drug Labeling and Warnings

Prenate Pixie by is a Prescription medication manufactured, distributed, or labeled by Avion Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Rx Only

DESCRIPTION: PRENATE PIXIE® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color, opaque, and imprinted with “PIX”.

OTHER INGREDIENTS: Capsule gelatin (gelatin, glycerin, purified water, titanium dioxide, FD&C red #40, caramel, and FD&C blue #1), palm shortening, soy lecithin, and yellow beeswax. PRENATE PIXIE® contains fish oil and soy.

INDICATIONS & USAGE

INDICATIONS: PRENATE PIXIE® 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.

BOXED WARNING

(What is this?)

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

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.

BOXED WARNING

(What is this?)

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

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 (75854-0316-30). 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.]

SPL UNCLASSIFIED SECTION

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. 5,516,925, 6,716,814, 8,007,846, and 8,425,956.

MANUFACTURED FOR:

Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30005

1-888-61-AVION

Rev. 0519-03

CONTRAINDICATIONS

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

PRINCIPAL DISPLAY PANEL

75854-0316-30

Prenate pixie®

Robust Rx Prenatal Vitamin with
11 concentrated nutrients and minerals

in a tiny softgel package

SUGAR FREE

GLUTEN FREE

LACTOSE FREE

Rx Only

Dietary Supplement

30 Softgels

INGREDIENTS AND APPEARANCE

PRENATE PIXIE 
ascorbic acid, biotin, cholecalciferol, cyanocobalamin, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, docusate sodium and blueberry tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 75854-316
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	30 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	75 ug
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	500 [iU]
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	13 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	400 ug
FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	10 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	150 ug
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	5 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	10 [iU]
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	200 mg
BLUEBERRY (UNII: 253RUG1X1A) (BLUEBERRY - UNII:253RUG1X1A)	BLUEBERRY	5 mg
LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLIC ACID	600 ug

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
YELLOW WAX (UNII: 2ZA36H0S2V)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CORN OIL (UNII: 8470G57WFM)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CARAMEL (UNII: T9D99G2B1R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	purple	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	PIX
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75854-316-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/15/2014

Labeler - Avion Pharmaceuticals, LLC (040348516)

Establishment
Name	Address	ID/FEI	Business Operations
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-316)