Label: 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
- NDC Code(s): 75854-308-30
- Packager: Avion Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated January 19, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- DESCRIPTION
- INACTIVE INGREDIENT
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INDICATIONS & USAGE
INDICATIONS: PRENATE ® Restore 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. PRENATE ® Restore can also be beneficial in improving the nutritional status of women prior to conception.
- CONTRAINDICATIONS
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BOXED WARNING
(What is this?)
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.
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PRECAUTIONS
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.
- BOXED WARNING (What is this?)
- ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
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HOW SUPPLIED
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 AND HANDLING
- WARNINGS
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SPL UNCLASSIFIED SECTION
MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, GA 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.
LactoSpore ® is a registered trademark of Sabinsa Corporation.
PRENATE ® is a registered trademark of Avion Pharmaceuticals, LLC. All rights reserved.
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.
- PRINCIPAL DISPLAY PANEL - 30 Softgel label
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INGREDIENTS AND APPEARANCE
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 coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75854-308 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 85 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 1000 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 10 [iU] FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 25 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 500 ug CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 155 mg FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 27 mg MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 45 mg LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID 10 mg DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 400 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) WHITE WAX (UNII: 7G1J5DA97F) CORN OIL (UNII: 8470G57WFM) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) Product Characteristics Color blue (dark blue) Score no score Shape OVAL Size 22mm Flavor Imprint Code OmegaRx Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75854-308-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/17/2013 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 (040348516) Establishment Name Address ID/FEI Business Operations Avion Pharmaceuticals, LLC 040348516 manufacture(75854-308)
