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.
Usual adult dose is 1 (one) softgel daily or as directed by a physician.
Rx Only
Prenaissance Capsules are a prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is brown in color, opaque and imprinted with “341” on one side.
EACH SOFTGEL CONTAINS:
| Vitamin C (ascorbic acid, USP) | 28 mg |
| Calcium (tricalcium phosphate, NF) | 160 mg |
| Iron (ferrous fumarate, USP) | 29 mg |
| Vitamin D3 (cholecalciferol, USP) | 800 IU |
| Vitamin E (d-alpha tocopherol, USP) | 30 IU |
| Vitamin B6 (pyridoxine HCl, USP) | 25 mg |
| Folic Acid, USP | 1.25 mg |
| DHA (docosahexaenoic acid) | 325 mg |
| Docusate Sodium, USP | 55 mg |
gelatin, glycerin, purified water, soybean oil, lecithin, yellow bees wax, natural creamy orange flavor, titanium dioxide, FD&C red #40, ethyl vanillin, FD&C yellow #5, FD&C blue #1.
Prenaissance Capsules are a multivitamin/multimineral nutritional supplement with DHA indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a physician.
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.
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.
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.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) daily.
Usual adult dose is 1 (one) softgel daily or as directed by a physician.
Prenaissance Capsules are supplied in child-resistant bottles of 30 softgels (NDC# 42192-341-30).
Store at 20° - 25°C (68° - 77°F) [See USP].
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.
MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30009
1-800-541-4802
Rev. 0411
NDC 42192-341-30
Prenaissance Capsules
Rx Prenatal Vitamin and DHA
Rx only 30 Softgels
Acella
PHARMACEUTICALS, LLC
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42192-341-30 | EA - Each | 42192-341 | da318935-466b-4d04-9548-2358b7e4b654 | 1 | 2013-02-13 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL, D- | ACTIVE INGREDIENT | N9PR3490H9 | 1 | |
| ASCORBIC ACID | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| DOCONEXENT | ACTIVE INGREDIENT | ZAD9OKH9JC | 1 | |
| DOCUSATE SODIUM | ACTIVE INGREDIENT | F05Q2T2JA0 | 1 | |
| FERROUS FUMARATE | ACTIVE INGREDIENT | R5L488RY0Q | 1 | |
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| PYRIDOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| TRICALCIUM PHOSPHATE | ACTIVE INGREDIENT | K4C08XP666 | 1 | |
| .ALPHA.-TOCOPHEROL, D- | ACTIVE MOIETY | N9PR3490H9 | 1 | |
| ASCORBIC ACID | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| DOCONEXENT | ACTIVE MOIETY | ZAD9OKH9JC | 1 | |
| DOCUSATE | ACTIVE MOIETY | M7P27195AG | 1 | |
| FERROUS CATION | ACTIVE MOIETY | GW89581OWR | 1 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| ETHYL VANILLIN | INACTIVE INGREDIENT | YC9ST449YJ | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| SOYBEAN OIL | INACTIVE INGREDIENT | 241ATL177A | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42192-341 | 42192-341-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASCORBIC ACID | PQ6CK8PD0R | ACTIB |
| TRICALCIUM PHOSPHATE | K4C08XP666 | ACTIM |
| FERROUS FUMARATE | R5L488RY0Q | ACTIM |
| CHOLECALCIFEROL | 1C6V77QF41 | ACTIB |
| .ALPHA.-TOCOPHEROL, D- | N9PR3490H9 | ACTIB |
| PYRIDOXINE HYDROCHLORIDE | 68Y4CF58BV | ACTIM |
| FOLIC ACID | 935E97BOY8 | ACTIB |
| DOCONEXENT | ZAD9OKH9JC | ACTIB |
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| SOYBEAN OIL | 241ATL177A | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| ETHYL VANILLIN | YC9ST449YJ | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| GELATIN | GELATIN | 2G86QN327L | TABLET, FILM COATED / ORAL | 57 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / INTRAVENOUS | 20 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, DELAYED RELEASE / ORAL | 3 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER / ORAL | 100 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 14 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SUPPOSITORY / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, COATED / ORAL | 213.7 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | POWDER / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER, FOR SUSPENSION / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / SUBLINGUAL | 13 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CONCENTRATE / ORAL | 0.04 mg/1ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| ETHYL VANILLIN | ETHYL VANILLIN | YC9ST449YJ | SYRUP / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| ETHYL VANILLIN | ETHYL VANILLIN | YC9ST449YJ | SUSPENSION / ORAL | 0.08 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, DELAYED RELEASE / ORAL | 1791 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / SUBCUTANEOUS | 16 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE / ORAL | 44 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SOLUTION / ORAL | 34.8 mg | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | INJECTION, EMULSION / INTRAVENOUS | 107100 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / SUBLINGUAL | 0.03 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg |
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 |
|---|---|---|---|---|---|---|
| 326f2d30-273f-90b4-e063-6394a90a0934 | 7240d5fb-cb2d-4278-988f-c8e6bba6560d | 2025-04-10 | Boxed warning, Warnings, Adverse reactions | 7240d5fb-cb2d-4278-988f-c8e6bba6560d |
Adverse event summaries are temporarily unavailable. Other product information remains available.