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 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
Rx Only Dietary Supplement
DESCRIPTION: PRENATE DHA® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color, opaque, and imprinted with “DHA” on one side and blank on the other. PRENATE DHA® can also be beneficial in improving the nutritional status of women prior to conception.
PRENATE DHA ® contains fish oil and soy.
OTHER INGREDIENTS: Gelatin capsule (FD&C Blue #1, FD&C Red #3, gelatin, glycerin, purified water, sorbitol and titanium dioxide), beeswax, soy lecithin, and soybean oil.
INDICATIONS: PRENATE DHA ® 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.
CONTRAINDICATIONS: PRENATE DHA ® 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 B 12 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: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.
HOW SUPPLIED: Bottles of 30 softgels (75854-312-30).
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.
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
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.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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.
PRENATE® is a registered trademark of Avion Pharmaceuticals, LLC. All rights reserved.
MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30005
1-888-61-AVION
L-0176 Rev 0325-02
75854-312-30
Prenate DHA ®
Rx prenatal vitamin & DHA
GLUTEN FREE
Rx Only
Dietary Supplement
30 Softgels
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 75854-312-30 | EA - Each | 75854-312 | 86c0e4df-d250-4c90-af9a-54bcc50f3be7 | 1 | 2014-08-01 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL, DL- | ACTIVE INGREDIENT | 7QWA1RIO01 | 2 | |
| ASCORBIC ACID | ACTIVE INGREDIENT | PQ6CK8PD0R | 2 | |
| CALCIUM FORMATE | ACTIVE INGREDIENT | NP3JD65NPY | 2 | |
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 2 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | 2 | |
| DOCONEXENT | ACTIVE INGREDIENT | ZAD9OKH9JC | 2 | |
| FERROUS ASPARTO GLYCINATE | ACTIVE INGREDIENT | H7426RGB3L | 2 | |
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | 2 | |
| MAGNESIUM OXIDE | ACTIVE INGREDIENT | 3A3U0GI71G | 2 | |
| PYRIDOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 68Y4CF58BV | 2 | |
| .ALPHA.-TOCOPHEROL, DL- | ACTIVE MOIETY | 7QWA1RIO01 | 2 | |
| ASCORBIC ACID | ACTIVE MOIETY | PQ6CK8PD0R | 2 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | 2 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 2 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 2 | |
| DOCONEXENT | ACTIVE MOIETY | ZAD9OKH9JC | 2 | |
| FERROUS CATION | ACTIVE MOIETY | GW89581OWR | 2 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 2 | |
| MAGNESIUM CATION | ACTIVE MOIETY | T6V3LHY838 | 2 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 2 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 2 | |
| SOYBEAN OIL | INACTIVE INGREDIENT | 241ATL177A | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 75854-312 | 75854-312-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LEVOMEFOLATE CALCIUM | A9R10K3F2F | ACTIM |
| GLYCERIN | PDC6A3C0OX | IACT |
| GELATIN | 2G86QN327L | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| SOYBEAN OIL | 241ATL177A | IACT |
| BEESWAX | 2ZA36H0S2V | IACT |
| WATER | 059QF0KO0R | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| FD&C RED NO. 3 | PN2ZH5LOQY | IACT |
| ASCORBIC ACID | PQ6CK8PD0R | ACTIB |
| CHOLECALCIFEROL | 1C6V77QF41 | ACTIB |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | WR1WPI7EW8 | ACTIM |
| FOLIC ACID | 935E97BOY8 | ACTIB |
| PYRIDOXINE HYDROCHLORIDE | 68Y4CF58BV | ACTIM |
| CYANOCOBALAMIN | P6YC3EG204 | ACTIB |
| CALCIUM FORMATE | NP3JD65NPY | ACTIM |
| FERROUS ASPARTO GLYCINATE | H7426RGB3L | ACTIM |
| MAGNESIUM OXIDE | 3A3U0GI71G | ACTIM |
| DOCONEXENT | ZAD9OKH9JC | ACTIB |
| SORBITOL | 506T60A25R | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 9 | 2026-04-17 | monthly-update | 2026-07-17 21:38:55 |
| 8 | 2026-04-13 | full-release | 2026-05-31 22:14:56 |
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 |
|---|---|---|---|---|---|---|
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CAPSULE, EXTENDED RELEASE / ORAL | 71 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, CHEWABLE / ORAL | 24 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CAPSULE, EXTENDED RELEASE / ORAL | 71 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | CAPSULE / ORAL | 1318 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, FILM COATED / ORAL | 57 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, DELAYED RELEASE / ORAL | 0.08 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SYRUP / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED / ORAL | 288 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / ORAL | 10932 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, EXTENDED RELEASE / ORAL | 14 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / ORAL | NA | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET / ORAL | 8 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| GELATIN | GELATIN | 2G86QN327L | ELIXIR / ORAL | NA | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, EXTENDED RELEASE / ORAL | 20 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, DELAYED RELEASE / ORAL | 1791 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, EXTENDED RELEASE / ORAL | 1229 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SYRUP / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, DELAYED RELEASE / ORAL | 1791 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| GELATIN | GELATIN | 2G86QN327L | PASTILLE / ORAL | 143 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED PELLETS / ORAL | 65 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| GELATIN | GELATIN | 2G86QN327L | WAFER / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / ORAL | 120 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 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 |
|---|---|---|---|---|---|---|
| 4faa7802-74fa-e413-e063-6394a90a9a49 | 8f2eca71-9a82-4a19-9206-36a04b865fe1 | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | 8f2eca71-9a82-4a19-9206-36a04b865fe1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.