PRENATE ELITE- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, calcium formate, ferrous asparto glycinate, cyanocobalamin, biotin, potassium iodide, magnesium oxide, zinc oxide and cupric oxide tablet, coated

Prenate Elite by

Drug Labeling and Warnings

Prenate Elite 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 ELITE ® is a white, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with “PN” on one side and blank on the other.

INACTIVE INGREDIENT

OTHER INGREDIENTS: Microcrystalline Cellulose, Silicon Dioxide, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Film Coating (Hydroxypropyl Methylcellulose, Triacetin, Titanium Dioxide).

INDICATIONS & USAGE

INDICATIONS: PRENATE ELITE ® 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

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

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 tablet daily or as directed by a physician.

HOW SUPPLIED

HOW SUPPLIED: Bottles of 30 tablets (75854-314-30). 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

Rev. 0519-01

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-314-30

Prenate Elite ®

PRENATAL VITAMINS-FILM-COATED TABLETS

GLUTEN FREE

Rx Only

Dietary Supplement

30 Tablets

INGREDIENTS AND APPEARANCE

PRENATE ELITE 
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, calcium formate, ferrous asparto glycinate, cyanocobalamin, biotin, potassium iodide, magnesium oxide, zinc oxide and cupric oxide tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 75854-314
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J)	.BETA.-CAROTENE	2600 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	75 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	600 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	40 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3.5 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	21 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	21 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	400 ug
5-METHYLTETRAHYDROFOLIC ACID (UNII: TYK22LML8F) (5-METHYLTETRAHYDROFOLIC ACID - UNII:TYK22LML8F)	5-METHYLTETRAHYDROFOLIC ACID	600 ug
CALCIUM FORMATE (UNII: NP3JD65NPY) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	155 mg
FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	20 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	13 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	330 ug
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	150 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	25 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	1.5 mg

Inactive Ingredients
Ingredient Name	Strength
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TRIACETIN (UNII: XHX3C3X673)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	PN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75854-314-30	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)

Establishment
Name	Address	ID/FEI	Business Operations
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-314)