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 one (1) softgel daily or as directed by a physician. KEEP OUT OF REACH OF CHILDREN.
Rx Only
PNV-DHA + Docusate is a prescription prenatal/postnatal multivitamin/multimineral softgel with DHA. Each softgel is red in color and imprinted with “323” on one side.
| |||
| SUPPLEMENT FACTS | |||
|---|---|---|---|
| Serving Size: 1 softgel | |||
| Amount Per
Serving | % Daily
Value | ||
| Vitamin C (as ascorbic acid, USP) | 28 mg | 47% | |
| Calcium (tribasic calcium phosphate, NF) | 160 mg | 16% | |
| Iron (as ferrous fumarate, USP) | 27 mg | 150% | |
| Vitamin D 3(as cholecalciferol, USP) | 400 IU | 100% | |
| Vitamin E (as d-alpha-tocopherol acetate, USP) | 30 IU | 100% | |
| Vitamin B 6(as pyridoxine HCl, USP) | 25 mg | 1250% | |
| Folic Acid, USP | 1.25 mg | 313% | |
| DHA (docosahexaenoic acid) | 300 mg | † | |
| Docusate sodium, USP | 55 mg | † | |
Bovine Gelatin, Glycerin, Soybean Oil, Soy Lecithin, Purified Water, Yellow Beeswax, FD&C Red # 40, Titanium Dioxide, Orange Cream Flavor, Ethyl Vanillin, FD&C Yellow # 6, and FD&C Blue #1. Contains soy.
PNV-DHA + Docusate is a multivitamin/mineral prescription dietary supplement indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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 B 12is 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.
CAUTION:Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 grams (1000 mg) daily.
Usual adult dose is one (1) softgel daily or as directed by a physician.
KEEP OUT OF REACH OF CHILDREN.
PNV-DHA + Docusate is supplied in child-resistant bottles of 30 softgels (42192-323-30). The listed product number is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and 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”]. Protect from light and heat.
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 dietary ingredients, other ingredients and information provided herein.
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.
MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30022
1-800-541-4802
Rev. 0717-01
42192-323-30
PNV-DHA+Docusate
R
xPrenatal Vitamin and DHA
Dietary Supplement
R xOnly 30 Softgels
Acella
PHARMACEUTICALS, LLC
| Class | Version | Type | Effective |
|---|---|---|---|
| ASCORBIC ACID Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CALCIUM Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230427 |
| CHOLECALCIFEROL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0342192323308 | GTIN-13: 0342192323308 EAN-13: 0342192323308 GTIN-12: 342192323308 UPC-A: 342192323308 GTIN storage (14 digits): 00342192323308 | 038fe2e7-dc16-485c-b5fb-746db7231347-01.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| 91c62db0-0295-c81c-d10a-0856c259edd6 | Product name | 2 | 20200428 |
| d32bc2b8-0bb7-2216-87aa-24639646e202 | Product name | 3 | 20190619 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42192-323-30 | PNV-DHA | 30 in 1 BOTTLE | CAPSULE, GELATIN COATED | 30 | 4 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42192-323-30 | EA - Each | 42192-323 | 560ec12f-69ba-41a0-b494-99af945ee1ad | 1 | 2018-02-20 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42192-323 | 42192-323-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GELATIN TYPE B BOVINE (230 BLOOM) | WIL1404U79 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SOYBEAN OIL | 241ATL177A | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| WATER | 059QF0KO0R | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ORANGE | 5EVU04N5QU | IACT |
| ETHYL VANILLIN | YC9ST449YJ | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| ASCORBIC ACID | PQ6CK8PD0R | ACTIB |
| CALCIUM | SY7Q814VUP | ACTIB |
| FERROUS FUMARATE | R5L488RY0Q | ACTIM |
| CHOLECALCIFEROL | 1C6V77QF41 | ACTIB |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | WR1WPI7EW8 | ACTIM |
| PYRIDOXINE | KV2JZ1BI6Z | ACTIB |
| FOLIC ACID | 935E97BOY8 | ACTIB |
| DOCONEXENT | ZAD9OKH9JC | ACTIB |
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 |
|---|---|---|---|---|---|---|
| PNV-DHA | ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CALCIUM, FERROUS FUMARATE, DOCONEXENT | Acella Pharmaceuticals, LLC | 576e8bbb-1625-493c-85da-43caf2f02e3c | 2026-03-04 | Boxed warning, Warnings, Adverse reactions | 42192-323-30 42192-323 42192032330 4c39225d-b6a1-5de2-e063-6294a90aa552 576e8bbb-1625-493c-85da-43caf2f02e3c |
Adverse event summaries are temporarily unavailable. Other product information remains available.