NDC 42192-321 Pnv-dha

Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine, Folic Acid, Cyanocobalamin, Calcium, Ferrous Fumarate, Magnesium, Doconexent

NDC Product Code 42192-321

NDC CODE: 42192-321

Proprietary Name: Pnv-dha What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine, Folic Acid, Cyanocobalamin, Calcium, Ferrous Fumarate, Magnesium, Doconexent What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is a multivitamin and iron product used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, or during pregnancy. Vitamins and iron are important building blocks of the body and help keep you in good health.

Product Characteristics

Color(s):
BLUE (C48333)
Shape: CAPSULE (C48336)
Size(s):
25 MM
Imprint(s):
BP;321
Score: 1

NDC Code Structure

  • 42192 - Acella Pharmaceuticals, Llc

NDC 42192-321-30

Package Description: 30 CAPSULE, GELATIN COATED in 1 BOTTLE

NDC Product Information

Pnv-dha with NDC 42192-321 is a a human prescription drug product labeled by Acella Pharmaceuticals, Llc. The generic name of Pnv-dha is ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium, doconexent. The product's dosage form is capsule, gelatin coated and is administered via oral form.

Labeler Name: Acella Pharmaceuticals, Llc

Dosage Form: Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Pnv-dha Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ASCORBIC ACID 85 [iU]/1
  • CHOLECALCIFEROL 200 [iU]/1
  • .ALPHA.-TOCOPHEROL ACETATE, DL- 10 [iU]/1
  • PYRIDOXINE 25 [iU]/1
  • FOLIC ACID 1 mg/1
  • CYANOCOBALAMIN 12 ug/1
  • CALCIUM 140 mg/1
  • FERROUS FUMARATE 27 mg/1
  • MAGNESIUM 45 mg/1
  • DOCONEXENT 300 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CORN OIL (UNII: 8470G57WFM)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 3 (UNII: PN2ZH5LOQY)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Ascorbic Acid - [CS]
  • Vitamin D - [CS]
  • Vitamin D - [EPC] (Established Pharmacologic Class)
  • Vitamin B6 Analog - [EPC] (Established Pharmacologic Class)
  • Vitamin B 6 - [Chemical/Ingredient]
  • Analogs/Derivatives - [Chemical/Ingredient]
  • Vitamin B 12 - [CS]
  • Vitamin B12 - [EPC] (Established Pharmacologic Class)
  • Calcium - [CS]
  • Calcium - [EPC] (Established Pharmacologic Class)
  • Phosphate Binder - [EPC] (Established Pharmacologic Class)
  • Phosphate Chelating Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Acella Pharmaceuticals, Llc
Labeler Code: 42192
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-02-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Pnv-dha Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx Only

Supplement FactsServing Size 1 TabletAmount Per


Serving


% DV %DV for Pregnant


or Lactating


Women


Vitamin C85 mg142%142%Vitamin D


3200 IU50%50%Vitamin E10 IU33%33%Vitamin D


625 mg1250%1000%Folate1 mg250%125%(L-methylfolate calcium 676 mcg (as Xolafin-B™


Percent Daily Values are based on a 2000 calorie diet)


molar equivalent to 600 mcg of Folic Acid)


(folic acid, USP 400 mcg)Vitamin B


1212 mcg200%150%Calcium140 mg14%11%Iron (ferrous fumarate)27 mg150%150%Magnesium45 mg11%10%Docosahexaenoic Acid (DHA)


(from omega-3 fatty acids)


300 mgDaily Value (DV) not established

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


9005 Westside Parkway


Alpharetta, GA 30009



1-800-541-4802


Rev. 04/10v6


*Xolafin-B™ is a trademark of Acella Pharmaceuticals, LLC

Description

DESCRIPTION: PNV-DHA is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel.
Each softgel is blue in color, opaque and imprinted with “BP 321” on one side.

Inactive Ingredient

OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3.

Indications & Usage

INDICATIONS: PNV-DHA is a multivitamin/multimineral nutritional supplement indicated for use in the dietary
management of patients with nutritional deficiencies or are in need of nutritional supplementation.

Contraindications

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the
ingredients.

Warnings

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.

Boxed Warning

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.

Precautions

PRECAUTIONS: 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.

Adverse Reactions

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.

How Supplied

HOW SUPPLIED: PNV-DHA is supplied in child-resistant bottles of 30 softgels (NDC# 42192-321-30).


Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

* Please review the disclaimer below.