TL-Care DHA
TL-Care DHA Softgels
FULL PRESCRIBING INFORMATION: CONTENTS*
- TL-CARE DHA DESCRIPTION
- INDICATIONS
- TL-CARE DHA CONTRAINDICATIONS
- WARNING
- PRECAUTION
- TL-CARE DHA ADVERSE REACTIONS
- HOW SUPPLIED
- STORAGE
- PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label
FULL PRESCRIBING INFORMATION
Rx Only
TL-CARE DHA 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 |
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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% |
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.
TL-CARE DHA 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.
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.
TL-CARE DHA 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.
Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).
KEEP OUT OF THE REACH OF CHILDREN.
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
13811-517-90
Rx Only
TL-Care DHA
Softgel Capsule
90 SOFTGELS
TRIGEN
LABORATORIES
TL-Care DHAFISH 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 CAPSULE
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