TL-Care DHA

Manufacturer
Trigen Laboratories, Inc.
Effective date
2013-05-20
Label type
DIETARY SUPPLEMENT
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:40:50

Label at a glance#

ProductTL-Care DHA
Active ingredientFISH OIL, DOCONEXENT, ICOSAPENT, THIAMINE MONONITRATE, RIBOFLAVIN, INOSITOL NIACINATE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FOLIC ACID, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, D-, BIOTIN, FERROUS FUMARATE, ZINC SULFATE MONOHYDRATE, CUPRIC SULFATE ANHYDROUS, DOCUSATE SODIUM
Label structure13 sections

Label contents#

Full prescribing information#

HEALTH CLAIM SECTION

Rx Only

DESCRIPTION

STATEMENT OF IDENTITY SECTION

TL-Care DHA is an orally administered prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish based DHA. Each softgel capsule is oblong, purple and imprinted with "TL517."

Supplement Facts
Servings per Bottle: 90
Serving Size: 1 Softgel Capsule
Each Softgel Capsule contains:
%DV for Pregnant and
Lactating Women
Fish Oil Concentrate 10/50 TG500 mg *
  DHA215 mg *
  EPA45 mg *
Vitamin B1 (thiamine nitrate)3 mg176%
Vitamin B2 (riboflavin)3.4 mg170%
Vitamin B3 (inositol nicotinate)20 mg100%
Vitamin B6 (pyridoxine HCl, USP)25 mg1000%
Vitamin B12 (cyanocobalamin)100 mcg1250%
Folic Acid1 mg125%
Vitamin C (ascorbic acid)60 mg100%
Vitamin D3 (cholecalciferol)800 IU200%
Vitamin E (d-alpha tocopherol)30 IU100%
Biotin300 mcg100%
Iron (ferrous fumarate)27 mg150%
Zinc (zinc sulfate monohydrate)10 mg67%
Copper (cupric sulfate anhydrous)2 mg100%
Docusate Sodium25 mg1.7%

* Daily value not established.

Inactive Ingredients: Gelatin, Glycerin, Purified Water, Sorbitol Special, Titanium Dioxide, Lemon Flavor, Carmine, and FD&C Blue #1.

INDICATIONS

HEALTH CLAIM SECTION

TL-Care DHA softgel capsules are indicated to provide vitamin/mineral and fish-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years.

TL-Care DHA may be useful in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS

HEALTH CLAIM SECTION

TL-Care DHA is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

WARNING

WARNINGS SECTION

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.

THIS PRODUCT CONTAINS FISH OIL AND SOY.

SAFE HANDLING WARNING 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.

PRECAUTION

PRECAUTIONS SECTION

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 remain progressive.

ADVERSE REACTIONS

HEALTH CLAIM SECTION

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

HOW SUPPLIED

HEALTH CLAIM SECTION

TL-Care DHA is supplied in child-resistant bottles of 30 or 90 softgel capsules each.

Product Code: 13811-517-30
Product Code: 13811-517-90

STORAGE

HEALTH CLAIM SECTION

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Contact with moisture may produce surface discoloration or erosion of the softgel.

HEALTH CLAIM SECTION

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

SAFE HANDLING WARNING SECTION

KEEP OUT OF THE REACH OF CHILDREN.

HEALTH CLAIM SECTION

Rx Only

All prescriptions using this product shall be pursuant to statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com

Rev. 03/13

PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

13811-517-90
Rx Only

TL-Care DHA

Softgel Capsule

90 SOFTGELS

TRIGEN
LABORATORIES

Principal Display Panel - 90 Capsule Bottle Label
Principal Display Panel - 90 Capsule Bottle Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-517-30EA - Each13811-517a8d03583-b9bd-4f92-82f2-41ecaef4512c12013-06-04
13811-517-90EA - Each13811-517a0d07144-0fcc-42a0-ba2e-8d08aa98768212013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROL, D-ACTIVE INGREDIENTN9PR3490H92
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0R2
BIOTINACTIVE INGREDIENT6SO6U10H042
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF412
CUPRIC SULFATE ANHYDROUSACTIVE INGREDIENTKUW2Q3U1VV2
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG2042
DOCONEXENTACTIVE INGREDIENTZAD9OKH9JC2
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA02
FERROUS FUMARATEACTIVE INGREDIENTR5L488RY0Q2
FISH OILACTIVE INGREDIENTXGF7L72M0F2
FOLIC ACIDACTIVE INGREDIENT935E97BOY82
ICOSAPENTACTIVE INGREDIENTAAN7QOV9EA2
INOSITOL NIACINATEACTIVE INGREDIENTA99MK953KZ2
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BV2
RIBOFLAVINACTIVE INGREDIENTTLM2976OFR2
THIAMINE MONONITRATEACTIVE INGREDIENT8K0I04919X2
ZINC SULFATE MONOHYDRATEACTIVE INGREDIENTPTX099XSF12
.ALPHA.-TOCOPHEROL, D-ACTIVE MOIETYN9PR3490H92
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0R2
BIOTINACTIVE MOIETY6SO6U10H042
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF412
CUPRIC CATIONACTIVE MOIETY8CBV67279L2
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2042
DOCONEXENTACTIVE MOIETYZAD9OKH9JC2
DOCUSATEACTIVE MOIETYM7P27195AG2
FERROUS CATIONACTIVE MOIETYGW89581OWR2
FISH OILACTIVE MOIETYXGF7L72M0F2
FOLIC ACIDACTIVE MOIETY935E97BOY82
ICOSAPENTACTIVE MOIETYAAN7QOV9EA2
INOSITOL NIACINATEACTIVE MOIETYA99MK953KZ2
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z2
RIBOFLAVINACTIVE MOIETYTLM2976OFR2
THIAMINE IONACTIVE MOIETY4ABT0J945J2
ZINC CATIONACTIVE MOIETY13S1S8SF372
diethylcarbamazineINACTIVE INGREDIENTV867Q8X3ZD2
FD&C blue No. 1INACTIVE INGREDIENTH3R47K3TBD2
gelatinINACTIVE INGREDIENT2G86QN327L2
glycerinINACTIVE INGREDIENTPDC6A3C0OX2
sorbitolINACTIVE INGREDIENT506T60A25R2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13811-51713811-517-30, 13811-517-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 240 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sorbitolSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION, SOLUTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY / VAGINALNAExact identifier — unii candidate
40 equally ranked IID candidates
FD&C blue No. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSOAP / TOPICAL1 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LPASTE / DENTAL252 mgExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
FD&C blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / SUBLINGUAL0.03 mgExact identifier — unii candidate
37 equally ranked IID candidates
gelatinGELATIN2G86QN327LTABLET, CHEWABLE / ORAL24 mgExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION / INTRAVENOUS20 mgExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / OPHTHALMIC6 mgExact identifier — unii candidate
44 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
gelatinGELATIN2G86QN327LDROPS / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
FD&C blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
gelatinGELATIN2G86QN327LCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRAVENOUS1276 mgExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION, SUSPENSION / INTRAMUSCULAR1.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
gelatinGELATIN2G86QN327LPOWDER / RESPIRATORY (INHALATION)100 mgExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LTABLET / PERIODONTAL3.44 mgExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LPASTILLE / ORAL143 mgExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, DELAYED RELEASE / ORAL66 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C blue No. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR14 mgExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25REMULSION / TOPICAL7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET / SUBLINGUAL50.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C blue No. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
gelatinGELATIN2G86QN327LTABLET / SUBLINGUAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPINSERT, EXTENDED RELEASE / OPHTHALMIC0.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR2 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii candidate
37 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates

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
OmegavenFISH OILFresenius Kabi USA, LLC5d9d0b24-e139-48bf-ab2d-536fb59cf8e02025-09-05Warnings, Adverse reactionsName fallback
generic name: FISH OIL

Reported adverse events (FAERS/openFDA)#

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