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TL-Care DHA

TRIGEN Laboratories, Inc.

TL-Care DHA Softgels


FULL PRESCRIBING INFORMATION: CONTENTS*




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
Serving Size: 1 Softgel Capsule
Each Softgel Capsule contains:
%DV for Pregnant and
Lactating Women
Fish Oil Concentrate 10/50 TG 500 mg  Daily value not established.
  DHA 215 mg  Daily value not established.
  EPA 45 mg  Daily value not established.
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 DHA

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 CAPSULE

Product Information

Product Type Dietary supplement Item Code (Source) NDC:13811-517
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FISH OIL 500 mg
DOCONEXENT DOCONEXENT 215 mg
ICOSAPENT ICOSAPENT 45 mg
THIAMINE MONONITRATE THIAMINE ION 3 mg
RIBOFLAVIN RIBOFLAVIN 3.4 mg
INOSITOL NIACINATE INOSITOL NIACINATE 20 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 25 mg
Cyanocobalamin CYANOCOBALAMIN 100 ug
FOLIC ACID FOLIC ACID 1 mg
ASCORBIC ACID ASCORBIC ACID 60 mg
CHOLECALCIFEROL CHOLECALCIFEROL 800 [iU]
.Alpha.-Tocopherol, D- .ALPHA.-TOCOPHEROL, D- 30 [iU]
BIOTIN 300 ug
FERROUS FUMARATE FERROUS CATION 27 mg
ZINC SULFATE MONOHYDRATE ZINC CATION 10 mg
Cupric Sulfate Anhydrous Cupric Cation 2 mg
DOCUSATE SODIUM DOCUSATE 25 mg

Inactive Ingredients

Ingredient Name Strength
GELATIN
GLYCERIN
water
sorbitol
titanium dioxide
diethylcarbamazine
FD&C BLUE NO. 1

Product Characteristics

Color Size Imprint Code Shape
PURPLE 26 mm TL517 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13811-517-30 30 in 1 BOTTLE
2 NDC:13811-517-90 90 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-04-29


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