Gesticare DHA

Jazz Pharmaceuticals Commercial Corp.

Gesticare® DHA Prenatal Multi-vitamin/Mineral Tablets with DHA and Choline

FULL PRESCRIBING INFORMATION: CONTENTS*

• GESTICARE DHA DESCRIPTION
  • Each tablet contains:
  • Inactive Ingredients:
  • Each DHA gelatin capsule contains:
• GESTICARE DHA INDICATIONS AND USAGE
• GESTICARE DHA CONTRAINDICATIONS
  • WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately
• WARNINGS
• PRECAUTIONS
• GESTICARE DHA ADVERSE REACTIONS
• GESTICARE DHA DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
• PRINCIPAL DISPLAY PANEL - Carton label for blister cards
• PRINCIPAL DISPLAY PANEL - Carton label for physician’s sample

FULL PRESCRIBING INFORMATION

GESTICARE DHA DESCRIPTION

Gesticare^® DHA includes a light pink coated oblong-shaped tablet with “P-114” debossed on one side of the tablet and a natural DHA softgel capsule containing a pale orange oil.

Each tablet contains:

Inactive Ingredients:

Microcrystalline Cellulose, Maltodextrin, Croscarmellose Sodium, Starch, Citric Acid, Silicon Dioxide, Magnesium Stearate, Stearic Acid, Calcium Sulfate, Bovine Gelatin Hydrolyzed, Sucrose, Partially Hydrogenated Soybean Oil, Dicalcium Phosphate, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc, FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake.

Each DHA gelatin capsule contains:

GESTICARE DHA INDICATIONS AND USAGE

Gesticare^® DHA is indicated to provide vitamin/mineral and DHA omega-3 fatty acid supplement to women throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Gesticare^® DHA may be beneficial in improving the nutritional status of women prior to conception.

GESTICARE DHA CONTRAINDICATIONS

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

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately

WARNINGS

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

PRECAUTIONS

Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

GESTICARE DHA ADVERSE REACTIONS

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

GESTICARE DHA DOSAGE AND ADMINISTRATION

One Gesticare^® tablet and one DHA capsule daily or as directed by a physician.

HOW SUPPLIED

Gesticare^® DHA 30 count is supplied as six child-resistant blister cards containing 5 Gesticare^® tablets and 5 DHA capsules each (NDC 18860-253-30).

Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°- 30ºC (59°-86°F).

Do not use if blister seal is broken.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

RX only

Distributed by:

Azur Pharma, Inc.

1818 Market Street, Suite 2350

Philadelphia, PA 19103

To report a serious adverse event or obtain product information, contact (800) 890 3098.

Gesticare^® is a registered trademark of Azur Pharma International II Limited.

life’s DHA is a trademark of Martek Biosciences Corporation.

PRINCIPAL DISPLAY PANEL - Carton label for blister cards

Gesticare _® DHA Prenatal Multi-Vitamin/Mineral Tablets
with DHA and Choline

NDC 18860-253-30 (30 Count)

6 Blister Cards; each containing
5 tablets and 5 capsules

PRINCIPAL DISPLAY PANEL - Carton label for physician’s sample

Gesticare _® DHA Prenatal Multi-Vitamin/Mineral Tablets
with DHA and Choline

Gesticare^® DHA is indicated for use in improving the nutritional status
of women throughout pregnancy and in the postnatal period for
both lactating and nonlactating mothers.

Gesticare^® DHA may be beneficial in improving the nutritional status of
women prior to conception.

PHYSICIAN'S SAMPLES (NDC 18860-253-00)

Contains 6 Patient Starter packages, each containing 2 tablets and 2 capsules

One tablet and one capsule daily or as directed by physician