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#
Contacts and useful links#
Label contents#
Full prescribing information#
HEALTH CLAIM SECTION
Rx Only
DESCRIPTION
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 TG | 500 mg | * |
| DHA | 215 mg | * |
| EPA | 45 mg | * |
| Vitamin B1 (thiamine nitrate) | 3 mg | 176% |
| Vitamin B2 (riboflavin) | 3.4 mg | 170% |
| Vitamin B3 (inositol nicotinate) | 20 mg | 100% |
| Vitamin B6 (pyridoxine HCl, USP) | 25 mg | 1000% |
| Vitamin B12 (cyanocobalamin) | 100 mcg | 1250% |
| Folic Acid | 1 mg | 125% |
| Vitamin C (ascorbic acid) | 60 mg | 100% |
| Vitamin D3 (cholecalciferol) | 800 IU | 200% |
| Vitamin E (d-alpha tocopherol) | 30 IU | 100% |
| Biotin | 300 mcg | 100% |
| Iron (ferrous fumarate) | 27 mg | 150% |
| Zinc (zinc sulfate monohydrate) | 10 mg | 67% |
| Copper (cupric sulfate anhydrous) | 2 mg | 100% |
| Docusate Sodium | 25 mg | 1.7% |
* Daily value not established.
Inactive Ingredients: Gelatin, Glycerin, Purified Water, Sorbitol Special, Titanium Dioxide, Lemon Flavor, Carmine, and FD&C Blue #1.
INDICATIONS
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
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
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
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
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
HOW SUPPLIED
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
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
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13811-517-30 | EA - Each | 13811-517 | a8d03583-b9bd-4f92-82f2-41ecaef4512c | 1 | 2013-06-04 |
| 13811-517-90 | EA - Each | 13811-517 | a0d07144-0fcc-42a0-ba2e-8d08aa987682 | 1 | 2013-06-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL, D- | ACTIVE INGREDIENT | N9PR3490H9 | 2 | |
| ASCORBIC ACID | ACTIVE INGREDIENT | PQ6CK8PD0R | 2 | |
| BIOTIN | ACTIVE INGREDIENT | 6SO6U10H04 | 2 | |
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 2 | |
| CUPRIC SULFATE ANHYDROUS | ACTIVE INGREDIENT | KUW2Q3U1VV | 2 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | 2 | |
| DOCONEXENT | ACTIVE INGREDIENT | ZAD9OKH9JC | 2 | |
| DOCUSATE SODIUM | ACTIVE INGREDIENT | F05Q2T2JA0 | 2 | |
| FERROUS FUMARATE | ACTIVE INGREDIENT | R5L488RY0Q | 2 | |
| FISH OIL | ACTIVE INGREDIENT | XGF7L72M0F | 2 | |
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | 2 | |
| ICOSAPENT | ACTIVE INGREDIENT | AAN7QOV9EA | 2 | |
| INOSITOL NIACINATE | ACTIVE INGREDIENT | A99MK953KZ | 2 | |
| PYRIDOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 68Y4CF58BV | 2 | |
| RIBOFLAVIN | ACTIVE INGREDIENT | TLM2976OFR | 2 | |
| THIAMINE MONONITRATE | ACTIVE INGREDIENT | 8K0I04919X | 2 | |
| ZINC SULFATE MONOHYDRATE | ACTIVE INGREDIENT | PTX099XSF1 | 2 | |
| .ALPHA.-TOCOPHEROL, D- | ACTIVE MOIETY | N9PR3490H9 | 2 | |
| ASCORBIC ACID | ACTIVE MOIETY | PQ6CK8PD0R | 2 | |
| BIOTIN | ACTIVE MOIETY | 6SO6U10H04 | 2 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 2 | |
| CUPRIC CATION | ACTIVE MOIETY | 8CBV67279L | 2 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 2 | |
| DOCONEXENT | ACTIVE MOIETY | ZAD9OKH9JC | 2 | |
| DOCUSATE | ACTIVE MOIETY | M7P27195AG | 2 | |
| FERROUS CATION | ACTIVE MOIETY | GW89581OWR | 2 | |
| FISH OIL | ACTIVE MOIETY | XGF7L72M0F | 2 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 2 | |
| ICOSAPENT | ACTIVE MOIETY | AAN7QOV9EA | 2 | |
| INOSITOL NIACINATE | ACTIVE MOIETY | A99MK953KZ | 2 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 2 | |
| RIBOFLAVIN | ACTIVE MOIETY | TLM2976OFR | 2 | |
| THIAMINE ION | ACTIVE MOIETY | 4ABT0J945J | 2 | |
| ZINC CATION | ACTIVE MOIETY | 13S1S8SF37 | 2 | |
| diethylcarbamazine | INACTIVE INGREDIENT | V867Q8X3ZD | 2 | |
| FD&C blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 2 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | 2 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- TL-Care DHA
- FISH 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, and DOCUSATE SODIUM
- FISH OIL
- DOCONEXENT
- ICOSAPENT
- THIAMINE MONONITRATE
- THIAMINE ION
- THIAMINE
- RIBOFLAVIN
- INOSITOL NIACINATE
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
- CYANOCOBALAMIN
- FOLIC ACID
- ASCORBIC ACID
- CHOLECALCIFEROL
- .ALPHA.-TOCOPHEROL, D-
- BIOTIN
- FERROUS FUMARATE
- FERROUS CATION
- ZINC SULFATE MONOHYDRATE
- ZINC CATION
- CUPRIC SULFATE ANHYDROUS
- CUPRIC CATION
- DOCUSATE SODIUM
- DOCUSATE
- gelatin
- glycerin
- water
- sorbitol
- titanium dioxide
- diethylcarbamazine
- FD&C blue No. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 13811-517 | 13811-517-30, 13811-517-90 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FISH OIL | XGF7L72M0F | ACTIB |
| DOCONEXENT | ZAD9OKH9JC | ACTIB |
| ICOSAPENT | AAN7QOV9EA | ACTIB |
| THIAMINE MONONITRATE | 8K0I04919X | ACTIR |
| RIBOFLAVIN | TLM2976OFR | ACTIB |
| INOSITOL NIACINATE | A99MK953KZ | ACTIB |
| PYRIDOXINE HYDROCHLORIDE | 68Y4CF58BV | ACTIB |
| CYANOCOBALAMIN | P6YC3EG204 | ACTIB |
| FOLIC ACID | 935E97BOY8 | ACTIB |
| ASCORBIC ACID | PQ6CK8PD0R | ACTIB |
| CHOLECALCIFEROL | 1C6V77QF41 | ACTIB |
| .ALPHA.-TOCOPHEROL, D- | N9PR3490H9 | ACTIB |
| BIOTIN | 6SO6U10H04 | ACTIB |
| FERROUS FUMARATE | R5L488RY0Q | ACTIM |
| ZINC SULFATE MONOHYDRATE | PTX099XSF1 | ACTIM |
| CUPRIC SULFATE ANHYDROUS | KUW2Q3U1VV | ACTIM |
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
| gelatin | 2G86QN327L | IACT |
| glycerin | PDC6A3C0OX | IACT |
| water | 059QF0KO0R | IACT |
| sorbitol | 506T60A25R | IACT |
| titanium dioxide | 15FIX9V2JP | IACT |
| diethylcarbamazine | V867Q8X3ZD | IACT |
| FD&C blue No. 1 | H3R47K3TBD | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| sorbitol | SORBITOL | 506T60A25R | INJECTION / INTRAMUSCULAR | NA | ||
| gelatin | GELATIN | 2G86QN327L | CAPSULE / ORAL | 10932 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| sorbitol | SORBITOL | 506T60A25R | INJECTION, SOLUTION / SUBCUTANEOUS | 4.7 %w/v | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| FD&C blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| sorbitol | SORBITOL | 506T60A25R | INJECTION / INTRASYNOVIAL | 45 %w/v | ||
| sorbitol | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| gelatin | GELATIN | 2G86QN327L | PASTE / DENTAL | 252 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| sorbitol | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| sorbitol | SORBITOL | 506T60A25R | SOLUTION/ DROPS / OPHTHALMIC | 0.25 %w/v | ||
| FD&C blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / SUBLINGUAL | 0.03 mg | ||
| gelatin | GELATIN | 2G86QN327L | TABLET, CHEWABLE / ORAL | 24 mg | ||
| gelatin | GELATIN | 2G86QN327L | INJECTION / INTRAVENOUS | 20 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SOLUTION / OPHTHALMIC | 6 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| gelatin | GELATIN | 2G86QN327L | DROPS / ORAL | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| FD&C blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| gelatin | GELATIN | 2G86QN327L | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| sorbitol | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| sorbitol | SORBITOL | 506T60A25R | INJECTION / INTRAVENOUS | 1276 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| gelatin | GELATIN | 2G86QN327L | INJECTION, SUSPENSION / INTRAMUSCULAR | 1.3 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| gelatin | GELATIN | 2G86QN327L | POWDER / RESPIRATORY (INHALATION) | 100 mg | ||
| gelatin | GELATIN | 2G86QN327L | TABLET / PERIODONTAL | 3.44 mg | ||
| gelatin | GELATIN | 2G86QN327L | PASTILLE / ORAL | 143 mg | ||
| gelatin | GELATIN | 2G86QN327L | CAPSULE, LIQUID FILLED / ORAL | 1042 mg | ||
| sorbitol | SORBITOL | 506T60A25R | INJECTION / SUBCUTANEOUS | 4.7 %w/v | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| FD&C blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE / DENTAL | NA | ||
| gelatin | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 14 mg | ||
| sorbitol | SORBITOL | 506T60A25R | EMULSION / TOPICAL | 7 %w/w | ||
| gelatin | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 14 mg | ||
| gelatin | GELATIN | 2G86QN327L | CAPSULE, DELAYED RELEASE / ORAL | 1791 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| FD&C blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SHAMPOO / TOPICAL | 0.75 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| gelatin | GELATIN | 2G86QN327L | TABLET / SUBLINGUAL | 19 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| gelatin | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 2 mg | ||
| FD&C blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| FD&C blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Omegaven | FISH OIL | Fresenius Kabi USA, LLC | 5d9d0b24-e139-48bf-ab2d-536fb59cf8e0 | 2025-09-05 | Warnings, Adverse reactions | FISH OIL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
