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Prenate Restore

Generic Name: ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent
Dosage Form: capsule, gelatin 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® Restore

Rx postnatal vitamin with probiotics and DHA

With
Quatrefolic®

Rx Only Dietary Supplement

DESCRIPTION: PRENATE® Restore is a prescription postnatal vitamin dietary supplement that contains probiotics, DHA and advanced calcium. Each dark blue softgel is imprinted with Omega Rx on one side and blank on the other.

*
Daily Value (DV) not established.
Supplement Facts
Serving Size: 1 Softgel
   
Amount per Serving: % Daily
Value
(Pregnant
Women)
% Daily
Value
(Lactating
Women)
Vitamin C (as Ascorbic Acid) 85 mg 142% 142%
Vitamin D3
(as Cholecalciferol)
1000 IU 250% 250%
Vitamin E
(as Dl-Alpha Tocopherol)
10 IU 33% 33%
Folate
(as 1.1mg Quatrefolic® ((6S)-5, Methyltetrahydrofolate Glucosamine Salt* CAS 1181972-37-1) molar equivalent to 600mcg of Folic Acid) (Folic Acid, USP 400mcg)
1 mg 250% 125%
Vitamin B6 (as Pyridoxine HCl) 25 mg 1000% 1000%
Vitamin B12
(as Cyanocobalamin)
12 mcg 200% 150%
Biotin 500 mg 167% 167%
Calcium (blend of Formical®
and Calcium Carbonate)
155 mg 16% 12%
Iron (as Ferrous Fumarate) 27 mg 150% 150%
Magnesium
(as Magnesium Oxide)
45 mg 11% 10%
Bacillus Coagulans
(as Lactospore®)
150 Million CFU
10 mg * *
Docosahexaenoic Acid
(DHA)
400 mg * *

OTHER INGREDIENTS: Bovine Gelatin, Glycerin, Soy Lecithin, White Beeswax, Vegetable Shortening, Purified Water, FD&C Blue #1, Titanium Dioxide and FD&C Red #3.

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.

INDICATIONS: PRENATE® Restore is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women during the postnatal period for both lactating and non-lactating mothers.

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

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: 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: One softgel daily, or as directed by a physician.

HOW SUPPLIED: Bottles of 30 softgels (75854-308-30). 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.]

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

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

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

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

Rev. 0913

PRINCIPAL DISPLAY PANEL - 30 Softgel label

75854-308-30

PRENATE® Restore
Rx postnatal vitamin with probiotics and DHA
with
Quatrefolic®

Rx Only
Dietary Supplement

30 Softgels

Avion
PHARMACEUTICALS

Prenate Restore 
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-308
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 85 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 1000 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 10 [iU]
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
BIOTIN (BIOTIN) BIOTIN 500 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 155 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 27 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 45 mg
LACTIC ACID (LACTIC ACID) LACTIC ACID 10 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 400 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
LECITHIN, SOYBEAN  
WHITE WAX  
CORN OIL  
WATER  
FD&C BLUE NO. 1  
TITANIUM DIOXIDE  
FD&C RED NO. 3  
Product Characteristics
Color BLUE (dark blue) Score no score
Shape OVAL Size 22mm
Flavor Imprint Code OmegaRx
Contains         
Packaging
# Item Code Package Description
1 NDC:75854-308-30 30 CAPSULE, GELATIN COATED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/17/2013
Labeler - Avion Pharmaceuticals, LLC (965450542)
Revised: 09/2013
 
Avion Pharmaceuticals, LLC



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