PRENATE DHA- ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent capsule, gelatin coated

PRENATE DHA by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx Only Dietary Supplement

DESCRIPTION

DESCRIPTION: PRENATE DHA ® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color, opaque, and imprinted with “DHA” on one side and blank on the other.

PRENATE DHA ® contains fish oil and soy.

INACTIVE INGREDIENT

OTHER INGREDIENTS: Gelatin capsule (FD&C Blue #1, FD&C Red #3, gelatin, glycerin, purified water, sorbitol and titanium dioxide), soybean oil, soy lecithin, and white beeswax.

INDICATIONS & USAGE

INDICATIONS: PRENATE DHA ® 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 DHA ® can also be beneficial in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS

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

WARNINGS

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 B 12 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 (75854-312-30).

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

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

MANUFACTURED FOR:

Avion Pharmaceuticals, LLC

Alpharetta, Georgia 30005

1-888-61-AVION

SPL UNCLASSIFIED SECTION

Formical ® is a registered trademark of Nephro-Tech 1, LLC, covered by one or more claims of U.S. Patent No. 6,528,542.

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.

PRENATE ® is a registered trademark of Avion Pharmaceuticals, LLC. Under license from Avion Pharmaceuticals, LLC.

All rights reserved.

Rev. 0519-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-312-30

Prenate DHA ®

Rx prenatal vitamin & DHA

• Key vitamins, minerals, and DHA support nutrition

GLUTEN FREE

Rx Only

Dietary Supplement

30 Softgels

INGREDIENTS AND APPEARANCE

PRENATE DHA 
ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent capsule, gelatin coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 75854-312
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	90 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	40 [iU]
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	26 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	25 ug
CALCIUM FORMATE (UNII: NP3JD65NPY) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	155 mg
FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	18 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	50 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	300 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SOYBEAN OIL (UNII: 241ATL177A)
WHITE WAX (UNII: 7G1J5DA97F)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)

Product Characteristics
Color	blue (opaque)	Score	no score
Shape	OVAL	Size	24mm
Flavor		Imprint Code	301
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75854-312-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/05/2014

Labeler - Avion Pharmaceuticals, LLC (040348516)

Registrant - Avion Pharmaceuticals, LLC (965450542)

Establishment
Name	Address	ID/FEI	Business Operations
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-312)