Label: PR NATAL 430 EC- beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron protein succinylate, ferrous bisglycinate, magnesium oxide, zinc oxide, cupric oxide tablet kit
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Contains inactivated NDC Code(s)
NDC Code(s): 42546-518-30 - Packager: PruGen, Inc Pharmaceuticals
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated October 1, 2012
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- Official Label (Printer Friendly)
- DESCRIPTION:
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INDICATIONS:
PR Natal 430 ec is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. PR Natal 430 ec is also useful in improving nutritional status prior to conception.
- CONTRAINDICATIONS:
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WARNINGS:PRECAUTIONS:
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Since daily ingestion of more than 3 grams per day of omega-3 fatty acids (including alphalinolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.
Folic acid especially in doses above 1.0 mg daily may obscure pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive). Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.
- BOXED WARNING (What is this?)
- DRUG INTERACTIONS:
- ADVERSE REACTIONS:
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED:
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STORAGE:DISPENSING:
Store at controlled room temperature 20°-25°C (68°-77°F). Protect from moisture and excessive heat. Note that contact with moisture may produce surface discolorations of the tablet.
Keep in a well-closed, light-resistant container. Supplied in a child-resistant bottle as a safeguard against ingestion by children. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
- Box Label
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INGREDIENTS AND APPEARANCE
PR NATAL 430 EC
beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron protein succinylate, ferrous bisglycinate, magnesium oxide, zinc oxide, cupric oxide tablet kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42546-518 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42546-518-30 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 30 Part 2 1 BOTTLE 30 Part 1 of 2 PR NATAL 430 EC
beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron protein succinylate, ferrous bisglycinate, magnesium oxide, zinc oxide, cupric oxide tablet tabletProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE 3000 [iU] ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 3 mg THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE ION 1.8 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 4 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 25 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN .012 mg CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 200 mg IRON PROTEIN SUCCINYLATE (UNII: VBJ9L90P4L) (IRON PROTEIN SUCCINYLATE - UNII:VBJ9L90P4L) IRON PROTEIN SUCCINYLATE 7.25 mg FERROUS BISGLYCINATE HYDROCHLORIDE (UNII: IW3QLZ8MRC) (IRON - UNII:E1UOL152H7) IRON 21.75 mg MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION 25 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 mg CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC OXIDE - UNII:V1XJQ704R4) CUPRIC OXIDE 2 mg Product Characteristics Color pink Score no score Shape capsule Size 19mm Flavor Imprint Code PE669 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2010 Part 2 of 2 PR NATAL 430 EC
omega 3 fatty acids capsule, gelatin coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS 430 mg Product Characteristics Color brown Score no score Shape capsule Size 19mm Flavor Imprint Code none Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 01/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2010 Labeler - PruGen, Inc Pharmaceuticals (929922750) Registrant - PruGen, Inc. Pharmaceuticals (929922750) Establishment Name Address ID/FEI Business Operations National Vitamin Company 102098324 manufacture(42546-518)