Prenate Elite

Generic Name: beta-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, zinc oxide and cupric oxide
Dosage Form: tablet, coated

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.

Prenate Elite®

PRENATAL VITAMINS-FILM COATED TABLETS

With
Quatrefolic®

Rx Only

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.

Supplement Facts
Serving Size: 1 Tablet
   
Amount per Serving: % Daily Value % Daily Value for
Lactating Women
Vitamin A (100% as beta-carotene) 2600 IU 50% 33%
Vitamin C (as ascorbic acid) 75 mg 125% 125%
Vitamin D3 (as cholecalciferol) 450 IU 113% 113%
Vitamin E (as dl-alpha tocopheryl acetate) 10 IU 33% 33%
Thiamin (as thiamin mononitrate) 3 mg 200% 176%
Riboflavin 3.5 mg 206% 175%
Niacin (as niacinamide ) 21 mg 105% 105%
Vitamin B6 (as pyridoxine HCl) 21 mg 1050% 840%
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 330 mcg 110% 110%
Pantothenic Acid (as calcium pantothenate) 6 mg 60% 60%
Calcium (as calcium carbonate) 100 mg 10% 8%
Iron (as ferrous fumarate) 26 mg 144% 144%
Iodine (as potassium iodine) 150 mcg 100% 100%
Magnesium (as magnesium oxide) 25 mg 6% 6%
Zinc (as zinc oxide) 15 mg 100% 100%
Copper (as copper oxide) 1.5 mg 75% 75%

OTHER INGREDIENTS: dicalcium phosphate, microcrystalline cellulose, stearic acid, aqueous coating, croscarmellose sodium, silica, magnesium stearate, titanium dioxide.

INDICATIONS: Prenate Elite® is a multivitamin/multimineral 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 Elite® can also be beneficial in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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.

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician.

HOW SUPPLIED: Prenate Elite® is supplied in child-resistant bottles of 30 (75854-301-30) or child-resistant bottles of 90 tablets (75854-301-90).

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

Rev. 022012

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-301-30         30 Tablets

Prenate Elite TM
PRENATAL VITAMINS-FILM-COATED TABLETS;
DHA®

with
Quatrefolic®

Prenate Elite 
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, zinc oxide and cupric oxide tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-301
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 2600 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 75 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 450 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 10 [iU]
THIAMINE (THIAMINE ION) THIAMINE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.5 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 21 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 21 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 13 ug
BIOTIN (BIOTIN) BIOTIN 330 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 6 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 100 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 26 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 150 ug
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 25 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 15 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 1.5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
CELLULOSE, MICROCRYSTALLINE  
STEARIC ACID  
CROSCARMELLOSE SODIUM  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 20mm
Flavor Imprint Code PN
Contains         
Packaging
# Item Code Package Description
1 NDC:75854-301-30 30 TABLET, COATED (CAPSULE) in 1 BOTTLE
2 NDC:75854-301-90 90 TABLET, COATED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/06/2012
Labeler - Avion Pharmaceuticals, LLC (965450542)
Revised: 05/2013
 
Avion Pharmaceuticals, LLC



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