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Prenate Star

Generic Name: prenatal vitamin
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® Star

Rx Only Dietary Supplement

DESCRIPTION: PRENATE® Star is a blue film coated tablet, engraved with “Prenate” on one side & “Star” on the other.

Supplement Facts
Serving Size: 1 Tablet
Amount per Serving:
Vitamin A (100% as beta-carotene) 3300 IU
Vitamin C (as ascorbic acid) 75 mg
Vitamin D3 (as cholecalciferol) 450 IU
Thiamin (as thiamine mononitrate) 1.5 mg
Riboflavin 2 mg
Niacinamide 21 mg
Vitamin B6 (as pyridoxine HCl) 21 mg
Folic Acid USP 1 mg
Vitamin B12 (as cyanocobalamin) 12 mcg
Biotin 330 mcg
Pantothenic Acid (as calcium pantothenate) 6 mg
Calcium (as Calcium Formate) “Formical®" 155 mg
Iron (as Ferrous Asparto Glycinate) "Sumalate®" 20 mg
Iodine (as potassium iodide) 150 mcg
Magnesium (as magnesium oxide) 25 mg
Zinc (as zinc oxide) 15 mg
Copper (as cupric oxide) 1.5 mg

OTHER INGREDIENTS: Cellulose, Silicon Dioxide, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Film Coating (Hydroxy Propyl Methyl Cellulose, Triacetin, Titanium Dioxide, FD&C Blue # 1, FD&C Blue # 2).

INDICATIONS: PRENATE® Star 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®Star 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.

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 (75854-311-30). 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. 0514

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-311-30

Prenate® Star
Certified Kosher Rx Prenatal Vitamin

Rx Only
Dietary Supplement

30 Tablets

Prenate® Star is Kosher Certified

AVION
PHARMACEUTICALS

Prenate Star 
.beta.-carotene, ascorbic acid, cholecalciferol, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, zinc oxide and cupric oxide tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-311
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 3300 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 75 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 450 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.5 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 2 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 21 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 21 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
BIOTIN (BIOTIN) BIOTIN 330 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 6 mg
CALCIUM FORMATE (CALCIUM CATION) CALCIUM CATION 155 mg
FERROUS ASPARTO GLYCINATE (FERROUS CATION) FERROUS CATION 20 mg
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  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 20mm
Flavor Imprint Code Prenate;Star
Contains         
Packaging
# Item Code Package Description
1 NDC:75854-311-30 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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