TL-Select

TRIGEN Laboratories, Inc.

TL-Select Softgel Capsules

FULL PRESCRIBING INFORMATION: CONTENTS*

• INDICATIONS
• TL-SELECT CONTRAINDICATIONS
• WARNING
• PRECAUTION
• TL-SELECT ADVERSE REACTIONS
• CAUTION
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

FULL PRESCRIBING INFORMATION

R_x Only

DESCRIPTION

TL-Select is a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish-based DHA. Each softgel capsule is oblong, brown and imprinted with "TL600".

• 1.25 mg Folic Acid and 325 mg DHA
  (key omega-3 fatty acid from purified fish oil.)
• Essential vitamins and minerals.

Inactive Ingredients: Gelatin, Glycerin, Purified Water, Soybean Oil, Lecithin, Yellow Beeswax, Natural Creamy Orange Flavor, Titanium Dioxide, Ethyl Vanillin, FD&C Red #40, FD&C Yellow #5, and FD&C Blue #1.

INDICATIONS

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

TL-SELECT CONTRAINDICATIONS

TL-Select 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 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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

TL-SELECT 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 is available in bottles of 30 softgel capsules.

Product Code: 13811-600-30

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 product. There are no implied or explicit claims on therapeutic equivalence.

R_x Only

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

TRIGEN
LABORATORIES

Rev. 11/12

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

13811-600-30
R_x Only

TL-Select
Softgel Capsule

• 1.25 mg Folic Acid and 325 mg DHA
  (key omega-3 fatty acid)
• Essential vitamins and minerals

30 CAPSULES

TRIGEN
LABORATORIES