NDC 42192-341 Prenaissance

Calcium Citrate, Iron Pentacarbonyl, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Docusate Sodium And Doconexent

NDC Product Code 42192-341

NDC CODE: 42192-341

Proprietary Name: Prenaissance 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: Calcium Citrate, Iron Pentacarbonyl, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Docusate Sodium And 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.

  • Drug uses not available
  • This medication is an iron supplement used to treat or prevent low blood levels of iron (e.g., for anemia or during pregnancy). Iron is an important mineral that the body needs to produce red blood cells and keep you in good health.
  • Folic acid is the man-made form of folate. Folate is a B-vitamin naturally found in some foods. It is needed to form healthy cells, especially red blood cells. Folic acid supplements may come in different forms (such as L-methylfolate, levomefolate, methyltetrahydrofolate). They are used to treat or prevent low folate levels. Low folate levels can lead to certain types of anemia. Conditions that can cause low folate levels include poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, among others. Women of childbearing age should receive adequate amounts of folic acid either through their diet or supplements to prevent infant spinal cord birth defects.
  • This medication is used to treat occasional constipation. Some medications and conditions can make constipation more likely. Stool softeners such as docusate are often the first method used for preventing and treating this type of constipation. Docusate is often used when straining to have a bowel movement should be avoided (e.g., after a heart attack or surgery). Docusate is a stool softener. It works by increasing the amount of water the stool absorbs in the gut, making the stool softer and easier to pass.

Product Characteristics

Color(s):
BROWN (C48332)
Shape: CAPSULE (C48336)
Size(s):
25 MM
Imprint(s):
341
Score: 1

NDC Code Structure

  • 42192 - Acella Pharmaceuticals, Llc

NDC 42192-341-30

Package Description: 30 CAPSULE, LIQUID FILLED in 1 CAPSULE

NDC Product Information

Prenaissance with NDC 42192-341 is a a human prescription drug product labeled by Acella Pharmaceuticals, Llc. The generic name of Prenaissance is calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium and doconexent. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Acella Pharmaceuticals, Llc

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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.

Prenaissance 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 28 mg/1
  • TRICALCIUM PHOSPHATE 160 mg/1
  • FERROUS FUMARATE 29 mg/1
  • CHOLECALCIFEROL 800 [iU]/1
  • .ALPHA.-TOCOPHEROL, D- 30 [iU]/1
  • PYRIDOXINE HYDROCHLORIDE 25 mg/1
  • FOLIC ACID 1.25 mg/1
  • DOCONEXENT 325 mg/1
  • DOCUSATE SODIUM 55 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.

  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • ETHYL VANILLIN (UNII: YC9ST449YJ)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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.
  • 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]
  • Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium - [CS]
  • Cations -
  • Divalent - [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]

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: 06-13-2011 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Prenaissance 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

EACH SOFTGEL CONTAINS:Vitamin C (ascorbic acid, USP)28 mgCalcium (tricalcium phosphate, NF)160 mgIron (ferrous fumarate, USP)29 mgVitamin D3 (cholecalciferol, USP)800 IUVitamin E (d-alpha tocopherol, USP)30 IUVitamin B6 (pyridoxine HCl, USP)25 mgFolic Acid, USP1.25 mgDHA (docosahexaenoic acid)325 mgDocusate Sodium, USP55 mg

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 1-800-541-4802Rev. 0411

Description:

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.

Other Ingredients:

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.

Indications:

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.

Contraindications:

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.

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:

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:

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 gram (1000 mg) daily.

Dosage And Administration:

Usual adult dose is 1 (one) softgel daily or as directed by a physician.

How Supplied:

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.

* Please review the disclaimer below.