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TL-Select DHA

TRIGEN Laboratories, Inc.

TL-Select DHA Softgel Capsules


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Rx Only

DESCRIPTION

TL-Select DHA Capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish-based DHA. Each softgel capsule is oblong, brown and imprinted with "TL507."

Supplement Facts
Servings per Bottle: 30
Serving Size: 1 Softgel Capsule %DV for Pregnant and
Each Softgel Capsule contains Lactating Women
Vitamin C (ascorbic acid, USP) 28 mg 47%
Vitamin D3 (cholecalciferol, USP) 800 IU 200%
Vitamin E (d-alpha tocopherol, USP) 30 IU 100%
Vitamin B6 (pyridoxine HCl, USP) 25 mg 1000%
Folic Acid, USP 1.25 mg 156%
Biotin 250 mcg 83%
Calcium 160 mg158 mg calcium from calcium cabonate, USP and 2 mg from docusate calcium, USP. 12%
Iron (ferrous fumarate, USP) 29 mg 161%
Fish oil blend 660 mg Providing 350 mg DHA (docosahexaenoic acid)
Docusate Calcium, USP 55 mg 4%
  • 1.25 mg Folic Acid and 350 mg DHA (key omega-3 fatty acid from purified fish oil.)
  • Essential vitamins and minerals.

THIS PRODUCT CONTAINS SOY AND FISH OIL.

Inactive Ingredients: Gelatin, glycerin, soy lecithin, beeswax, water, sorbitol/sorbitan, titanium dioxide, FD&C Red #40, FD&C Yellow #5, and FD&C Blue #1.

INDICATIONS

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

TL-SELECT DHA CONTRAINDICATIONS

TL-Select DHA Capsules are 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.

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.

THIS PRODUCT CONTAINS SOY AND FISH OIL.

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 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

TL-SELECT DHA ADVERSE REACTIONS

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

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

HOW SUPPLIED

TL-Select DHA Capsules are available in bottles of 30 softgel capsules.

Product Code: 13811-507-30

STORAGE

Store at 20° - 25°C (68° - 77°F), excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature].

KEEP OUT OF THE REACH OF CHILDREN.

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

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

Rx Only

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

Rev. 12/12

PRINCIPAL DISPLAY PANEL - 30 capsule Bottle Label

13811-507-30
Rx Only

TL-Select DHA
Softgel Capsule

  • 1.25 mg Folic Acid and 350 mg DHA
    (key omega-3 fatty acid)
  • Essential vitamins and minerals

30 CAPSULES

TRIGEN
LABORATORIES

TL-Select DHA

TL-Select DHA

ASCORBIC ACID, .ALPHA.-TOCOPHEROL, D-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, TRIBASIC CALCIUM PHOSPHATE, FERROUS FUMARATE, CHOLECALCIFEROL, FISH OIL, DOCUSATE SODIUM, and BIOTIN CAPSULE

Product Information

Product Type Dietary supplement Item Code (Source) NDC:13811-507
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ASCORBIC ACID ASCORBIC ACID 28 mg
.Alpha.-Tocopherol, D- .ALPHA.-TOCOPHEROL, D- 30 [iU]
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 25 mg
FOLIC ACID FOLIC ACID 1.25 mg
TRIBASIC CALCIUM PHOSPHATE CALCIUM CATION 160 mg
FERROUS FUMARATE FERROUS CATION 29 mg
CHOLECALCIFEROL CHOLECALCIFEROL 800 [iU]
FISH OIL 600 mg
DOCUSATE SODIUM DOCUSATE 55 mg
BIOTIN 250 ug

Inactive Ingredients

Ingredient Name Strength
GELATIN
GLYCERIN
water
sorbitol
SORBITAN
LECITHIN, SOYBEAN
YELLOW WAX
titanium dioxide
ETHYL VANILLIN
FD&C RED NO. 40
FD&C YELLOW NO. 5
FD&C BLUE NO. 1

Product Characteristics

Color Size Imprint Code Shape
BROWN 26 mm TL507 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13811-507-30 30 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-12-01


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