Prenate Elite

Generic Name: multivitamin/multimineral
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®

Rx Only Dietary Supplement

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
(Pregnant
& Lactating
Women
Vitamin A (100% as beta-carotene) 2600 IU 52% 33%
Vitamin C (as ascorbic acid) 75 mg 125% 125%
Vitamin D3 (as cholecalciferol) 600 IU 150% 150%
Vitamin E (as dl-alpha tocopheryl acetate) 40 IU 133% 133%
Thiamin (as thiamine mononitrate) 3 mg 200% 176%
Riboflavin 3.5 mg 206% 175%
Niacinamide 21 mg 105% 105%
Vitamin B6 (as pyridoxine HCl) 21 mg 1050% 840%
Folate
(as 1.11 mg of ((6S)-N5-methyltetrahydrofolic acid calcium salt (molar equivalent to 600 mcg of folic acid) and folic acid, USP 400 mcg)
1 mg 250% 125%
Calcium (as calcium formate) Formical® 155 mg 16% 12%
Iron (as ferrous asparto glycinate) Sumalate® 20 mg 111% 111%
Vitamin B12 (as cyanocobalamin) 13 mcg 217% 163%
Biotin 330 mcg 110% 110%
Iodine (as potassium iodide) 150 mcg 100% 100%
Magnesium (as magnesium oxide) 25 mg 6% 6%
Zinc (as zinc oxide) 15 mg 100% 100%
Copper (as cupric oxide) 1.5 mg 75% 75%

OTHER INGREDIENTS: Cellulose, Silicon Dioxide, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Film Coating (Hydro Propyl Methyl Cellulose, Triacetin, Titanium Dioxide).

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: Prenate Elite® is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

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.

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 tablet daily or as directed by a physician.

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: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

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.

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 Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.

MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30022
1-888-61-AVION

Rev. 0614

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-314-30

Prenate Elite ®
PRENATAL VITAMINS-FILM-COATED TABLETS

GLUTEN FREE
Rx Only
Dietary Supplement

30 Tablets

AVION
PHARMACEUTICALS

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 LABEL Item Code (Source) NDC:75854-314
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 600 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 40 [iU]
THIAMINE MONONITRATE (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 400 ug
5-METHYLTETRAHYDROFOLIC ACID (5-METHYLTETRAHYDROFOLIC ACID) 5-METHYLTETRAHYDROFOLIC ACID 600 ug
CALCIUM FORMATE (CALCIUM CATION) CALCIUM CATION 155 mg
FERROUS ASPARTO GLYCINATE (FERROUS CATION) FERROUS CATION 20 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 13 ug
BIOTIN (BIOTIN) BIOTIN 330 ug
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 150 ug
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 25 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 15 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 1.5 mg
Inactive Ingredients
Ingredient Name Strength
POWDERED CELLULOSE  
SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
STEARIC ACID  
MAGNESIUM STEARATE  
HYPROMELLOSES  
TRIACETIN  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 20mm
Flavor Imprint Code PN
Contains         
Packaging
# Item Code Package Description
1 NDC:75854-314-30 30 TABLET, COATED (CAPSULE) in 1 BOTTLE
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 (965450542)
Revised: 07/2014
 
Avion Pharmaceuticals, LLC



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