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.
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.
PR Natal 430 ec is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements, supplied as tablets and softgel capsules.
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.
This product is contraindicated in patients with known hypersensitivity to any of the ingredients including fish or fish oil.
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.
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.
Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Before, during and after pregnancy, one tablet and one softgel capsule taken by mouth daily, or as directed by a physician. The tablet and softgel capsule may be taken together or at different times of the day.
A 30-day supply of PR Natal 430 ec (NDC 42546-518-30) is supplied in 2 bottles with child-resistant caps. One bottle contains 30 pink-brown oval tablets imprinted with ‘PE 669’ on one side. A second bottle contains 30 frosted golden-colored oval enteric-coated DHA softgel capsules.
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.
NDC 42546-518-30
PR Natal 430 ec
| Class | Version | Type | Effective |
|---|---|---|---|
| ASCORBIC ACID Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CALCIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230427 |
| CHOLECALCIFEROL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| MAGNESIUM CATION Pharmacologic Class Indexing | 4 | Indexing - Pharmacologic Class | 20180813 |
| OMEGA-3 FATTY ACIDS Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42546-518-30 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d406-cd31-e053-dbdaa90ab51a | PR Natal 430 ec |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42546-518-30 | PR Natal 430 ec | 1 in 1 KIT | KIT | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 42546-518 | 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 [PRUGEN, INC PHARMACEUTICALS] | 1 | Legacy NDC, 1 package rows | 20121002_0b2d95e4-5846-47dd-bddf-53a7db0dadbe.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42546-518-30 | EA - Each | 42546-518 | 9a1a0014-6abd-441f-8158-23b7b1e71232 | 1 | 2013-02-13 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL ACETATE, DL- | ACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| ASCORBIC ACID | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| BETA CAROTENE | ACTIVE INGREDIENT | 01YAE03M7J | 1 | |
| CALCIUM CARBONATE | ACTIVE INGREDIENT | H0G9379FGK | 1 | |
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| CUPRIC OXIDE | ACTIVE INGREDIENT | V1XJQ704R4 | 1 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| FERROUS BISGLYCINATE HYDROCHLORIDE | ACTIVE INGREDIENT | IW3QLZ8MRC | 1 | |
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| IRON PROTEIN SUCCINYLATE | ACTIVE INGREDIENT | VBJ9L90P4L | 1 | |
| MAGNESIUM OXIDE | ACTIVE INGREDIENT | 3A3U0GI71G | 1 | |
| NIACINAMIDE | ACTIVE INGREDIENT | 25X51I8RD4 | 1 | |
| OMEGA-3 FATTY ACIDS | ACTIVE INGREDIENT | 71M78END5S | 1 | |
| PYRIDOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| RIBOFLAVIN | ACTIVE INGREDIENT | TLM2976OFR | 1 | |
| THIAMINE MONONITRATE | ACTIVE INGREDIENT | 8K0I04919X | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| .ALPHA.-TOCOPHEROL, DL- | ACTIVE MOIETY | 7QWA1RIO01 | 1 | |
| ASCORBIC ACID | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| BETA CAROTENE | ACTIVE MOIETY | 01YAE03M7J | 1 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| CUPRIC OXIDE | ACTIVE MOIETY | V1XJQ704R4 | 1 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| IRON | ACTIVE MOIETY | E1UOL152H7 | 1 | |
| IRON PROTEIN SUCCINYLATE | ACTIVE MOIETY | VBJ9L90P4L | 1 | |
| MAGNESIUM CATION | ACTIVE MOIETY | T6V3LHY838 | 1 | |
| NIACINAMIDE | ACTIVE MOIETY | 25X51I8RD4 | 1 | |
| OMEGA-3 FATTY ACIDS | ACTIVE MOIETY | 71M78END5S | 1 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| RIBOFLAVIN | ACTIVE MOIETY | TLM2976OFR | 1 | |
| THIAMINE ION | ACTIVE MOIETY | 4ABT0J945J | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42546-518 | 42546-518-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BETA CAROTENE | 01YAE03M7J | ACTIM |
| ASCORBIC ACID | PQ6CK8PD0R | ACTIM |
| CHOLECALCIFEROL | 1C6V77QF41 | ACTIM |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | WR1WPI7EW8 | ACTIM |
| THIAMINE MONONITRATE | 8K0I04919X | ACTIM |
| RIBOFLAVIN | TLM2976OFR | ACTIM |
| NIACINAMIDE | 25X51I8RD4 | ACTIM |
| PYRIDOXINE HYDROCHLORIDE | 68Y4CF58BV | ACTIM |
| FOLIC ACID | 935E97BOY8 | ACTIM |
| CYANOCOBALAMIN | P6YC3EG204 | ACTIM |
| CALCIUM CARBONATE | H0G9379FGK | ACTIM |
| IRON PROTEIN SUCCINYLATE | VBJ9L90P4L | ACTIM |
| FERROUS BISGLYCINATE HYDROCHLORIDE | IW3QLZ8MRC | ACTIM |
| MAGNESIUM OXIDE | 3A3U0GI71G | ACTIM |
| ZINC OXIDE | SOI2LOH54Z | ACTIM |
| CUPRIC OXIDE | V1XJQ704R4 | ACTIM |
| OMEGA-3 FATTY ACIDS | 71M78END5S | ACTIM |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9e43a416-3601-44e3-be7f-9132594aedaa | 0b2d95e4-5846-47dd-bddf-53a7db0dadbe | 2012-10-01 | Boxed warning, Warnings, Adverse reactions | 9e43a416-3601-44e3-be7f-9132594aedaa 0b2d95e4-5846-47dd-bddf-53a7db0dadbe |
Adverse event summaries are temporarily unavailable. Other product information remains available.