Concept DHA

Manufacturer
U.S. Pharmaceutical Corporation
Effective date
2022-11-08
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 20:44:55

Label at a glance#

ProductConcept DHA
Active ingredientFERROUS FUMARATE, IRON, ASCORBIC ACID, FOLIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACIN, CALCIUM PANTOTHENATE, PYRIDOXINE HYDROCHLORIDE, BIOTIN, CYANOCOBALAMIN, CUPRIC SULFATE, MAGNESIUM SULFATE, UNSPECIFIED FORM, ZINC SULFATE, UNSPECIFIED FORM, OMEGA-3-ACID ETHYL ESTERS
Label structure2 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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 C‡)    .    .    .    .    .    .    .    .    .    .    .    .    25 mg FolicAcid.............................. 1mg ThiamineMononitrate(B1) ................ 2mg Riboflavin(B2) .......................... 3mg Niacin (B3, from ProAscorb C‡)    .    .    .    .    .    .    .    .    .    .    .    .    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 SECTION

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 & USAGE SECTION

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 PRECAUTIONS SECTION

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 & ADMINISTRATION SECTION

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 SECTION

HOW SUPPLIED: Concept DHATM 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.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Concept DHAConcept DHA

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813
NIACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
OMEGA-3 FATTY ACIDS Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
95250459-30e4-45c1-b08a-993044f49109Product name220250805
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52747-621-302022-08-12C16284748780-1956f9ecf-ca50-621f-e053-dbdaa90a74adsee all prescribing information for Concept DHA
52747-621-302019-10-21C16284748780-1956f9ecf-ca50-621f-e053-dbdaa90a74adsee all prescribing information for Concept DHA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52747-621-30Concept DHA30 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52747-621CONCEPT DHA (VITAMIN- MINERAL OMEGA-3 SUPPLEMENT) CAPSULE, LIQUID FILLED [U.S. PHARMACEUTICAL CORPORATION]5Current NDC, Legacy NDC, 1 package rows20221110_bd2051f7-b887-46f6-8d4a-b099fcd08629.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52747-621-30EA - Each52747-621a585753a-aaa7-4510-8c41-1ef37f0b1e9912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0R1
BIOTINACTIVE INGREDIENT6SO6U10H041
CALCIUM PANTOTHENATEACTIVE INGREDIENT568ET80C3D1
CUPRIC SULFATEACTIVE INGREDIENTLRX7AJ16DT1
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG2041
FERROUS FUMARATEACTIVE INGREDIENTR5L488RY0Q1
FOLIC ACIDACTIVE INGREDIENT935E97BOY81
IRONACTIVE INGREDIENTE1UOL152H71
MAGNESIUM SULFATEACTIVE INGREDIENTDE08037SAB1
NIACINACTIVE INGREDIENT2679MF687A1
OMEGA-3-ACID ETHYL ESTERSACTIVE INGREDIENTD87YGH4Z0Q1
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BV1
RIBOFLAVINACTIVE INGREDIENTTLM2976OFR1
THIAMINE MONONITRATEACTIVE INGREDIENT8K0I04919X1
ZINC SULFATEACTIVE INGREDIENT89DS0H96TB1
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0R1
BIOTINACTIVE MOIETY6SO6U10H041
CALCIUM PANTOTHENATEACTIVE MOIETY568ET80C3D1
COPPERACTIVE MOIETY789U1901C51
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2041
FOLIC ACIDACTIVE MOIETY935E97BOY81
IRONACTIVE MOIETYE1UOL152H71
MANGANESEACTIVE MOIETY42Z2K6ZL8P1
NIACINACTIVE MOIETY2679MF687A1
OMEGA-3-ACID ETHYL ESTERSACTIVE MOIETYD87YGH4Z0Q1
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z1
RIBOFLAVINACTIVE MOIETYTLM2976OFR1
THIAMINEACTIVE MOIETYX66NSO3N351
ZINCACTIVE MOIETYJ41CSQ7QDS1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52747-62152747-621-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Concept DHAVITAMIN- MINERAL OMEGA-3 SUPPLEMENTU.S. Pharmaceutical Corporationbd2051f7-b887-46f6-8d4a-b099fcd086292022-11-08WarningsExact identifier
ndc (package): 52747-621-30
ndc (product): 52747-621
ndc11 (package): 52747062130
spl id: aaee698d-9522-49c9-afd3-d0c5d52e3ccd
spl set id: bd2051f7-b887-46f6-8d4a-b099fcd08629

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.