UltimateCare ONE

TRIGEN Laboratories, Inc.

UltimateCare ONE Prenatal

FULL PRESCRIBING INFORMATION: CONTENTS*

• ULTIMATECARE ONE DESCRIPTION
  • Inactive Ingredients
• INDICATIONS
• ULTIMATECARE ONE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • Pediatric Use
  • Geriatric Use
• ADVERSE REACTION
• ULTIMATECARE ONE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL - 30 Softgel Capsule Bottle Label

FULL PRESCRIBING INFORMATION

Rx Only

ULTIMATECARE ONE DESCRIPTION

UltimateCare ONE is a prescription prenatal/postnatal multivitamin/mineral capsule with omega-3 fatty acids. Each maroon softgel capsule is imprinted with "TL049."

Supplement Facts Servings per Bottle: 30
Serving Size: 1 Softgel Capsule Each Softgel Capsule contains	DV% for Pregnant and Lactating Women
Omega-3 Fatty Acids	330 mg	Daily value not established.
Docosahexaenoic Acid (DHA)	260 mg	Daily value not established.
Eicosapentaenoic Acid (EPA)	40 mg	Daily value not established.
a-Linoleic Acid (ALA)	30 mg	Daily value not established.
Linoleic Acid	30 mg	Daily value not established.
Vitamin C ComplexVitamin C Complex is a pharmaceutical grade material consisting of calcium ascorbate and calcium threonate.	25 mg	42%
Vitamin D3 (cholecalciferol)	170 IU	43%
Vitamin E (dl-alpha-tocopheryl acetate)	30 IU	100%
Folic Acid, USP	1 mg	125%
Vitamin B6 (pyridoxine HCl)	25 mg	1000%
Calcium (calcium carbonate)	150 mg	12%
Iron
Carbonyl iron (elemental iron)	20 mg	111%
Sumalate™Sumalate™ (ferrous asparto glycinate) is a trademark of Albion International, Inc., Clearfield, Utah. (elemental iron)	7 mg	39%

Inactive Ingredients

Gelatin, Glycerin, Lecithin, Purified Water, Natural Creamy Orange Flavor, Carmine, Titanium Dioxide, Ethyl Vanillin, FD&C Red #40, FD&C Blue #1.

INDICATIONS

UltimateCare ONE is indicated to provide vitamin/mineral and omega-3 fatty acid supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. It is also useful for improving nutritional status prior to conception.

ULTIMATECARE ONE CONTRAINDICATIONS

This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

WARNINGS

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

THIS PRODUCT CONTAINS SOY.

PRECAUTIONS

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac functions, and of concomitant disease or other drug therapy.

ADVERSE REACTION

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

ULTIMATECARE ONE DOSAGE AND ADMINISTRATION

Usual dosage is one capsule daily, or as prescribed by a physician.

HOW SUPPLIED

UltimateCare ONE is Supplied in bottles of 30 capsules.

PRODUCT CODE 13811-049-30

STORAGE

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

Protect from moisture and excessive heat.

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. 02/13

PRINCIPAL DISPLAY PANEL - 30 Softgel Capsule Bottle Label

13811-049-30
R_x Only

UltimateCare
ONE

Prenatal with DHA & EPA

30 Softgel Capsules

TRIGEN
LABORATORIES