Concept Dha
Vitamin- Mineral Omega-3 Supplement
U.s. Pharmaceutical Corporation
Human Prescription Drug
NDC 52747-621Concept Dha also known as Vitamin- Mineral Omega-3 Supplement is a human prescription drug labeled by 'U.s. Pharmaceutical Corporation'. National Drug Code (NDC) number for Concept Dha is 52747-621. This drug is available in dosage form of Capsule, Liquid Filled. The names of the active, medicinal ingredients in Concept Dha drug includes Ascorbic Acid - 25 mg/1 Biotin - 300 ug/1 Calcium Pantothenate - 5 mg/1 Cupric Sulfate - 2 mg/1 Cyanocobalamin - 12.5 ug/1 Ferrous Fumarate - 17.5 mg/1 Folic Acid - 1 mg/1 Iron - 17.5 mg/1 Magnesium Sulfate, Unspecified Form - 5 mg/1 Niacin - 1.8 mg/1 and more. The currest status of Concept Dha drug is Active.
Drug Information:
| Drug NDC: | 52747-621 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Concept Dha |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Vitamin- Mineral Omega-3 Supplement |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | U.s. Pharmaceutical Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule, Liquid Filled |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ASCORBIC ACID - 25 mg/1
BIOTIN - 300 ug/1
CALCIUM PANTOTHENATE - 5 mg/1
CUPRIC SULFATE - 2 mg/1
CYANOCOBALAMIN - 12.5 ug/1
FERROUS FUMARATE - 17.5 mg/1
FOLIC ACID - 1 mg/1
IRON - 17.5 mg/1
MAGNESIUM SULFATE, UNSPECIFIED FORM - 5 mg/1
NIACIN - 1.8 mg/1
Load more...OMEGA-3-ACID ETHYL ESTERS - 200 mg/1
PYRIDOXINE HYDROCHLORIDE - 25 mg/1
RIBOFLAVIN - 3 mg/1
THIAMINE MONONITRATE - 2 mg/1
ZINC SULFATE, UNSPECIFIED FORM - 10 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 24 Jun, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 01 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | U.S. Pharmaceutical Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000193618
M0001797
M0022794
N0000175951
N0000175594
M0014839
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | PQ6CK8PD0R
6SO6U10H04
568ET80C3D
LRX7AJ16DT
P6YC3EG204
R5L488RY0Q
935E97BOY8
E1UOL152H7
DE08037SAB
2679MF687A
Load more...D87YGH4Z0Q
68Y4CF58BV
TLM2976OFR
8K0I04919X
89DS0H96TB
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Vitamin C [EPC]
Vitamin B12 [EPC]
Nicotinic Acid [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Ascorbic Acid [CS]
Vitamin B 12 [CS]
Nicotinic Acids [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Analogs/Derivatives [Chemical/Ingredient]
Ascorbic Acid [CS]
Calculi Dissolution Agent [EPC]
Copper Absorption Inhibitor [EPC]
Decreased Copper Ion Absorption [PE]
Fatty Acids
Omega-3 [CS]
Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
Magnesium Ion Exchange Activity [MoA]
Nicotinic Acid [EPC]
Nicotinic Acids [CS]
Omega-3 Fatty Acid [EPC]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
Vitamin B 12 [CS]
Vitamin B 6 [Chemical/Ingredient]
Vitamin B12 [EPC]
Vitamin B6 Analog [EPC]
Vitamin C [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 52747-621-30 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (52747-621-30) | 24 Jun, 2009 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Concept dha vitamin- mineral omega-3 supplement ferrous fumarate ferrous cation iron iron ascorbic acid ascorbic acid folic acid folic acid thiamine mononitrate thiamine ion thiamine riboflavin riboflavin niacin niacin calcium pantothenate pantothenic acid pyridoxine hydrochloride pyridoxine biotin biotin cyanocobalamin cyanocobalamin cupric sulfate cupric cation magnesium sulfate, unspecified form magnesium cation zinc sulfate, unspecified form zinc cation omega-3-acid ethyl esters omega-3 fatty acids yellow wax hypromellose, unspecified titanium dioxide fd&c red no. 40 pink concept;dha;us
Indications and Usage:
Indications: concept dhatm is a prescription prenatal vitamin-mineral preparation containing omega-3 fatty acid supplements designed to supply nutritional supplementation for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. concept dhatm may also be used to improve the nutritional status of women before conception.
Warnings and Cautions:
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. warning: ingestion of more than 3 grams of omega-3 fatty acids from fish oils per day may have potential antithrombotic effects, including an increased bleeding time and inr (international normalized ratio). dha should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants. warning: folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where vitamin b12 is deficient. precautions: general: folic acid in doses above 0.1 mg - 0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.
Dosage and Administration:
Dosage and administration: adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician. do not exceed recommended dosage. do not administer to children under the age of 12.
Description:
Description: each capsule contains: ferrous fumarate (elemental iron) . . . . . . . . . . 17.5 mg polysaccharideironcomplex(elementaliron).. 17.5mg (equivalent to about 35 mg of elemental iron) vitamin c (from proascorb câ¡) . . . . . . . . . . . . 25 mg folicacid.............................. 1mg thiaminemononitrate(b1) ................ 2mg riboflavin(b2) .......................... 3mg niacin (b3, from proascorb câ¡) . . . . . . . . . . . . 1.8 mg d-calciumpantothenate(b5)................ 5mg pyridoxinehci(b6) .................... 25mg biotin (b7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300 mcg cyanocobalamin(b12) ................ 12.5mcg copper(ascoppersulfate).................. 2mg magnesium(asmagnesiumsulfate) . . . . . . . . zinc(aszincsulfate).................... omega-3 fatty acids . . . . . . . . . ........... (derived from 310 mg fish oil) docosahexaenoic acid (dha) . ........... eicosapentaenoic acid (epa) . ........... . 5mg 10mg 200 mg156 mg 39 mg clinical studies: because ferrous fumarate is an organic complex, it contains no free ions, either ferric or ferrous. polysaccharide iron complex is clinically non-toxic. prior studies in rats demonstrated that polysaccharide iron complex (pic), administered as a single oral dose to sprague dawley rats did not produce evidence of toxicity at a dosage level of 5000 mg iron/kg: (an acute oral toxicity study in rats with polysaccharide-iron complex. t.n.merriman, m. aikman and r.e. rush, springborn laboratories, inc. spencerville, ohio study no. 3340.1 march - april 1994). other clinical studies had demonstrated that polysaccharide iron gives a good hematopoietic response with an almost complete absence of the side effects usually associated with oral iron therapy. picinni and ricciotti suggested in 1982, that "the therapeutic effectiveness of polysaccharide iron complex when compared with iron fumarate in the treatment of iron deficiency anemia, appears to be as active as the iron fumarate and as well tolerated, however, it exerted a greater influence on the level of hemoglobin and on the number of red cells..." and that, "it has been exceptionally well tolerated by all patients" (picinni, l.-ricciotti, m. 1982. therapeutic effectiveness of an iron-polysaccharide complex in comparison with iron fumarate in the treatment of iron deficiency anemias): panminerva medica-europa medica, vol. 24, no. 3, pp. 213-220 (july - september 1982). as mentioned above, the patented source of iron used in concept dhatm (ferrous fumarate and polysaccharide iron complex) provides a high level of elemental iron with a low incidence of gastric distress. conclusion: based on the results of this study, the oral combination of ferrous fumarate and polysaccharide iron complex was better tolerated and safer than the oral administration of ferrous fumarate alone. the conclusion of this research stated, that the addition of pic to ferrous fumarate surprisingly allows the same concentration of ferrous fumarate to be better tolerated than the ferrous fumarate alone. indications: concept dhatm is a prescription prenatal vitamin-mineral preparation containing omega-3 fatty acid supplements designed to supply nutritional supplementation for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. concept dhatm may also be used to improve the nutritional status of women before conception. 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. warning: ingestion of more than 3 grams of omega-3 fatty acids from fish oils per day may have potential antithrombotic effects, including an increased bleeding time and inr (international normalized ratio). dha should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants. warning: folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where vitamin b12 is deficient. precautions: general: folic acid in doses above 0.1 mg - 0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive. dosage and administration: adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician. do not exceed recommended dosage. do not administer to children under the age of 12. how supplied: concept dha tm are red maroon opaque vcaps ® capsules printed in white with "concept dha" on the cap "us" logo on the body. packed in child-resistant cap and light resistant bottle of 30 capsules (52747-0621-30). the listed product number is not a national drug code. instead, us pharmaceutical corporation has assigned this product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems. 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. vcaps ® and the vcaps ® logo are trademarks used under license.
Clinical Studies:
Clinical studies: because ferrous fumarate is an organic complex, it contains no free ions, either ferric or ferrous. polysaccharide iron complex is clinically non-toxic. prior studies in rats demonstrated that polysaccharide iron complex (pic), administered as a single oral dose to sprague dawley rats did not produce evidence of toxicity at a dosage level of 5000 mg iron/kg: (an acute oral toxicity study in rats with polysaccharide-iron complex. t.n.merriman, m. aikman and r.e. rush, springborn laboratories, inc. spencerville, ohio study no. 3340.1 march - april 1994). other clinical studies had demonstrated that polysaccharide iron gives a good hematopoietic response with an almost complete absence of the side effects usually associated with oral iron therapy. picinni and ricciotti suggested in 1982, that "the therapeutic effectiveness of polysaccharide iron complex when compared with iron fumarate in the treatment of iron deficiency anemia, appears to be as active as the iron fumara
Read more...te and as well tolerated, however, it exerted a greater influence on the level of hemoglobin and on the number of red cells..." and that, "it has been exceptionally well tolerated by all patients" (picinni, l.-ricciotti, m. 1982. therapeutic effectiveness of an iron-polysaccharide complex in comparison with iron fumarate in the treatment of iron deficiency anemias): panminerva medica-europa medica, vol. 24, no. 3, pp. 213-220 (july - september 1982). as mentioned above, the patented source of iron used in concept dhatm (ferrous fumarate and polysaccharide iron complex) provides a high level of elemental iron with a low incidence of gastric distress. conclusion: based on the results of this study, the oral combination of ferrous fumarate and polysaccharide iron complex was better tolerated and safer than the oral administration of ferrous fumarate alone. the conclusion of this research stated, that the addition of pic to ferrous fumarate surprisingly allows the same concentration of ferrous fumarate to be better tolerated than the ferrous fumarate alone.
How Supplied:
How supplied: concept dha tm are red maroon opaque vcaps ® capsules printed in white with "concept dha" on the cap "us" logo on the body. packed in child-resistant cap and light resistant bottle of 30 capsules (52747-0621-30). the listed product number is not a national drug code. instead, us pharmaceutical corporation has assigned this product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems. 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. vcaps ® and the vcaps ® logo are trademarks used under license.
Package Label Principal Display Panel:
Packaging concept dha