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NDC 42192-0323-30 PNV-DHA 30; 28; 160; 400; 300; 27; 1.25; 25 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 Details
PNV-DHA 30; 28; 160; 400; 300; 27; 1.25; 25 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1
PNV-DHA is a ORAL CAPSULE, GELATIN COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Acella Pharmaceuticals, LLC. The primary component is .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CALCIUM; CHOLECALCIFEROL; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; PYRIDOXINE.
Product Information
| NDC | 42192-0323 |
|---|---|
| Product ID | 42192-323_6b5cbe1c-348f-43f0-85fb-3a927e5ad4d8 |
| Associated GPIs | 78516037000138 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | PNV-DHA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, calcium, ferrous fumarate, doconexent |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, GELATIN COATED |
| Route | ORAL |
| Active Ingredient Strength | 30; 28; 160; 400; 300; 27; 1.25; 25 |
| Active Ingredient Units | [iU]/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 |
| Substance Name | .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CALCIUM; CHOLECALCIFEROL; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; PYRIDOXINE |
| Labeler Name | Acella Pharmaceuticals, LLC |
| Pharmaceutical Class | Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 42192-0323-30 (42192032330)
| NDC Package Code | 42192-323-30 |
|---|---|
| Billing NDC | 42192032330 |
| Package | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (42192-323-30) |
| Marketing Start Date | 2010-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 576e8bbb-1625-493c-85da-43caf2f02e3c Details
DESCRIPTION
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.
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† Daily Value (DV) not established. |
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| 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 D3 (as cholecalciferol, USP) | 400 IU | 100% | |
| Vitamin E (as d-alpha-tocopherol acetate, USP) | 30 IU | 100% | |
| Vitamin B6 (as pyridoxine HCl, USP) | 25 mg | 1250% | |
| Folic Acid, USP | 1.25 mg | 313% | |
| DHA (docosahexaenoic acid) | 300 mg | † | |
| Docusate sodium, USP | 55 mg | † | |
OTHER INGREDIENTS
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.
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.
WARNING
PRECAUTIONS
ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION
HOW SUPPLIED
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
PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets
INGREDIENTS AND APPEARANCE
| PNV-DHA
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, calcium, ferrous fumarate, doconexent capsule, gelatin coated |
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| Labeler - Acella Pharmaceuticals, LLC (825380939) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Acella Pharmaceuticals, LLC | 825380939 | manufacture(42192-323) | |