Gesticare DHA

Generic Name: prenatal multi-vitamin/mineral
Dosage Form: tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

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:

Vitamin B1 (Thiamin Mononitrate) 3 mg
Vitamin B2 (Riboflavin) 3 mg
Vitamin B6 (Pyridoxine HCl) 50 mg
Vitamin B12 (Cyanocobalamin) 8 µg
Vitamin C (Ascorbic acid) 120 mg
Niacin (Niacinamide) 20 mg
Folic acid 1 mg
Iron (Ferrous Fumarate) 27 mg
Calcium (Calcium Carbonate) 200 mg
Vitamin D3 (Cholecalciferol) 410 IU
Vitamin E (DL-Alpha Tocopheryl Acetate) 30 IU
Iodine (Potassium Iodide) 150 µg
Zinc (Zinc Oxide) 15 mg
Choline (Choline Bitartrate) 55 mg

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:

DHA is an omega-3 fatty acid. The DHA in Gesticare® DHA is derived from Algal Oil (C.cohnii). 625 mg of Algal Oil is equivalent to250 mg of DHA.

Other ingredients in the DHA gelatin capsule: High Oleic Sunflower Oil, Ascorbyl Palmitate, Tocopherols, Gelatin (Bovine), Glycerin,Polysorbate 80.

Docosahexaenoic Acid (DHA) from Algal Oil 250 mg
Eicosapentaenoic Acid (EPA) Not more than 0.625mg

Indications and Usage for Gesticare DHA

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.

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.

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 is Gesticare DHA 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

Gesticare DHA 
thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, choline bitartrate, doconexent, and icosapent kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:18860-253
Packaging
# Item Code Package Description
1 NDC:18860-253-30 6 BLISTER PACK in 1 CARTON
1 1 KIT in 1 BLISTER PACK
2 NDC:18860-253-00 6 BLISTER PACK in 1 CARTON
2 1 KIT in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1
Part 2
Part 3
Part 4
Part 1 of 4
GESTICARE 
thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, and choline bitartrate tablet
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 50 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 8 ug
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
NIACIN (NIACIN) NIACIN 20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
FERROUS FUMARATE (IRON) FERROUS FUMARATE 27 mg
CALCIUM CARBONATE (CARBONATE ION) CALCIUM CARBONATE 200 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 410 [iU]
.ALPHA.-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL ACETATE 30 [iU]
POTASSIUM IODIDE (IODINE) POTASSIUM IODIDE 150 ug
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 15 mg
CHOLINE BITARTRATE (CHOLINE) CHOLINE BITARTRATE 55 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
CITRIC ACID MONOHYDRATE  
TALC  
MALTODEXTRIN  
FD&C RED NO. 40  
TITANIUM DIOXIDE  
STEARIC ACID  
CELLULOSE, MICROCRYSTALLINE  
STARCH, POTATO  
CALCIUM SULFATE  
GELATIN  
SUCROSE  
SOYBEAN OIL  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
POLYVINYL ALCOHOL  
POLYETHYLENE GLYCOLS  
FD&C YELLOW NO. 6  
FD&C BLUE NO. 1  
Product Characteristics
Color pink (P-114, light, coated) Score no score
Shape CAPSULE (oblong) Size 19mm
Flavor Imprint Code
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/01/2009
Part 2 of 4
DHA 
doconexent and icosapent capsule, gelatin coated
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 250 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 0.625 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
SUNFLOWER OIL  
ASCORBYL PALMITATE  
POLYSORBATE 80  
TOCOPHEROL  
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Dietary Supplement 09/01/2009
Part 3 of 4
GESTICARE 
thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, and choline bitartrate tablet
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 50 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 8 ug
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
NIACIN (NIACIN) NIACIN 20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
FERROUS FUMARATE (IRON) FERROUS FUMARATE 27 mg
CALCIUM CARBONATE (CARBONATE ION) CALCIUM CARBONATE 200 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 410 [iU]
.ALPHA.-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL ACETATE 30 [iU]
POTASSIUM IODIDE (IODINE) POTASSIUM IODIDE 150 ug
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 15 mg
CHOLINE BITARTRATE (CHOLINE) CHOLINE BITARTRATE 55 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
CITRIC ACID MONOHYDRATE  
TALC  
MALTODEXTRIN  
FD&C RED NO. 40  
TITANIUM DIOXIDE  
STEARIC ACID  
CELLULOSE, MICROCRYSTALLINE  
STARCH, POTATO  
CALCIUM SULFATE  
GELATIN  
SUCROSE  
SOYBEAN OIL  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
POLYVINYL ALCOHOL  
POLYETHYLENE GLYCOLS  
FD&C YELLOW NO. 6  
FD&C BLUE NO. 1  
Product Characteristics
Color pink (P-114, light, coated) Score no score
Shape CAPSULE (oblong) Size 19mm
Flavor Imprint Code
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/01/2009
Part 4 of 4
DHA 
doconexent and icosapent capsule, gelatin coated
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 250 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 0.625 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
SUNFLOWER OIL  
ASCORBYL PALMITATE  
POLYSORBATE 80  
TOCOPHEROL  
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Dietary Supplement 09/01/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/01/2008
Labeler - Jazz Pharmaceuticals Commercial Corp. (805611071)
Revised: 06/2012
 
Jazz Pharmaceuticals Commercial Corp.
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