NDC 23359-105 C-nate Dha

Omega-3 Fatty Acids, Icosapent, Doconexent, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol, D-, Cupric Sulfate, Zinc Oxide, Ferrous Fumarate And Magnesium Oxide

NDC Product Code 23359-105

NDC CODE: 23359-105

Proprietary Name: C-nate 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: Omega-3 Fatty Acids, Icosapent, Doconexent, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol, D-, Cupric Sulfate, Zinc Oxide, Ferrous Fumarate And Magnesium Oxide 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.

  • Cyanocobalamin is a man-made form of vitamin B12 used to treat low levels (deficiency) of this vitamin. Vitamin B12 helps your body use fat and carbohydrates for energy and make new protein. It is also important for normal blood, cells, and nerves. Most people get enough vitamin B12 in their diet, but a deficiency may occur in certain health conditions (e.g., poor nutrition, stomach/intestinal problems, infection, cancer). Serious vitamin B12 deficiency may result in anemia, stomach problems, and nerve damage.
  • 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.
  • Drug uses not available
  • This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.
  • 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.
  • This medication is a mineral supplement used to prevent and treat low amounts of magnesium in the blood. Some brands are also used to treat symptoms of too much stomach acid such as stomach upset, heartburn, and acid indigestion. Magnesium is very important for the normal functioning of cells, nerves, muscles, bones, and the heart. Usually, a well-balanced diet provides normal blood levels of magnesium. However, certain situations cause your body to lose magnesium faster than you can replace it from your diet. These situations include treatment with water pills (diuretics such as furosemide, hydrochlorothiazide), a poor diet, alcoholism, or other medical conditions (e.g., severe diarrhea/vomiting, stomach/intestinal absorption problems, poorly controlled diabetes).

Product Characteristics

Color(s):
BROWN (C48332 - ANNATO)
Shape: CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
PRE;01
Score: 1

NDC Code Structure

NDC 23359-105-01

Package Description: 1 CAPSULE, GELATIN COATED in 1 PACKET

NDC 23359-105-05

Package Description: 5 CAPSULE, GELATIN COATED in 1 CARTON

NDC 23359-105-30

Package Description: 30 CAPSULE, GELATIN COATED in 1 BOTTLE

NDC Product Information

C-nate Dha with NDC 23359-105 is a a human prescription drug product labeled by Centurion Labs, Llc. The generic name of C-nate Dha is omega-3 fatty acids, icosapent, doconexent, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, cholecalciferol, ascorbic acid, .alpha.-tocopherol, d-, cupric sulfate, zinc oxide, ferrous fumarate and magnesium oxide. The product's dosage form is capsule, gelatin coated and is administered via oral form.

Labeler Name: Centurion Labs, 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.

C-nate 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.

  • OMEGA-3 FATTY ACIDS 200 mg/1
  • THIAMINE MONONITRATE 3 mg/1
  • RIBOFLAVIN 3 mg/1
  • PYRIDOXINE HYDROCHLORIDE 20 mg/1
  • CYANOCOBALAMIN 15 ug/1
  • FOLIC ACID 1 mg/1
  • CHOLECALCIFEROL 400 [iU]/1
  • ASCORBIC ACID 100 mg/1
  • .ALPHA.-TOCOPHEROL, D- 30 [iU]/1
  • CUPRIC SULFATE 1 mg/1
  • ZINC OXIDE 20 mg/1
  • FERROUS FUMARATE 28 mg/1
  • MAGNESIUM 30 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)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • WATER (UNII: 059QF0KO0R)

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.

  • Copper Absorption Inhibitor - [EPC] (Established Pharmacologic Class)
  • Decreased Copper Ion Absorption - [PE] (Physiologic Effect)
  • Fatty Acids -
  • Omega-3 - [CS]
  • Omega-3 Fatty Acid - [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)
  • Vitamin D - [CS]
  • Vitamin D - [EPC] (Established Pharmacologic Class)
  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Ascorbic Acid - [CS]

Product Labeler Information

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

Labeler Name: Centurion Labs, Llc
Labeler Code: 23359
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: 01-01-2013 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’.

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C-nate 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

PRENATAL / MULTIVITAMINRev. 10/12Rx ONLY

CENTURION LABS, LLCBIRMINGHAM, AL 35243

Description

Each Softgel Contains:Omega-3 Fatty Acids (DHA-EPA)200mgVitamin B1 (Thiamine Mononitrate)3 mgVitamin B2 (Riboflavin)3 mgVitamin B6 (Pyridoxine HCL)20 mgVitamin B12 (Cyanocobalamin)15 mcgFolic Acid1 mgVitamin D3 (Cholecalciferol)400 IUVitamin C (Ascorbic Acid)100 mgVitamin E (d-alpha tocopherol)30 IUCopper (Cupric Sulfate)1 mgZinc (Zinc Oxide)20 mgIron (Fumerate)28 mgMagnesium30 mg

Inactive Ingredient

INACTIVE INGREDIENTS: Gelatin, Glycerol, beeswax yellow, lecithin, water-purified and colorant.

Indications & Usage

INDICATIONS AND USAGE: C-NATE DHA is a prescription multivitamin/multimineral 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.

Contraindications

CONTRAINDICATIONS: C-NATE DHA should not be used by patients with known history of hypersensitivity to any of the listed ingredients.

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 0.1 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.

Warnings

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.

Pediatric Use

PEDIATRIC USE: Safety and effectiveness in pediactric patients has not been established.

Geriatric Use

GERIACTRIC USE: No clinical studies have been performed in patients over 65 to determine whether older persons respond differently from younger persons. Physicians should consider that elderly person may have decreased hepatic, renal, or cardiac function.

Drug Interactions

DRUG INTERACTIONS: C-NATE DHA softgels are not recommended for and should not be given to patients receiving levodopa because the action
of levodopa is antagonized by pyridoxine.

Adverse Reactions

ADVERSE REACTIONS: Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has
been associated with gastrointestinal intolerance in some patients.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Usual adult dose: one softgel daily or as prescribed by your doctor.

How Supplied

HOW SUPPLIED: C-NATE DHA is available as a Annato colored softgel, imprinted PRE 01. Available in 30 count bottles with NDC #23359-105-30 and samples with NDC #23359-105-05 and NDC #23359-105-01.PHYSICIAN SAMPLE NOT FOR RESALE

Storage And Handling

Recommended Storage: 15°-30°C (59°-86°F) degrees. Protect from light moisture and avoid excessive heat. Dispense original carton.KEEP OUT OF REACH OF CHILDRENRX ONLY

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