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   
Azur Pharma, Inc.

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.

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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 acid1 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 Oil250 mg
Eicosapentaenoic Acid (EPA)Not more than 0.625mg

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.

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.

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.

life's DHA logo

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 Delayed-Release 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 Blister Cards

PRINCIPAL DISPLAY PANEL - Carton label for physician’s sample

Gesticare® DHA Delayed-Release 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 is also 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

Principal Display Panel - Carton Label for Physician's Sample

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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:18860-253
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:18860-253-306 BLISTER PACK in 1 CARTONcontains a BLISTER PACK
11 KIT in 1 BLISTER PACKThis package is contained within the CARTON (18860-253-30)
2NDC:18860-253-006 BLISTER PACK in 1 CARTONcontains a BLISTER PACK
21 KIT in 1 BLISTER PACKThis package is contained within the CARTON (18860-253-00)
QUANTITY OF PARTS
Part #Package QuantityTotal 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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN3 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE50 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN8 ug
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID120 mg
NIACIN (NIACIN) NIACIN20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID1 mg
FERROUS FUMARATE (IRON) FERROUS FUMARATE27 mg
CALCIUM CARBONATE (CARBONATE ION) CALCIUM CARBONATE200 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL410 [iU]
VITAMIN E ACETATE (VITAMIN E) VITAMIN E ACETATE30 [iU]
POTASSIUM IODIDE (IODINE) POTASSIUM IODIDE150 ug
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE15 mg
CHOLINE BITARTRATE (CHOLINE) CHOLINE BITARTRATE55 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
COLLOIDAL SILICON DIOXIDE 
MAGNESIUM STEARATE 
CITRIC ACID 
TALC 
MALTODEXTRIN 
FD&C RED NO. 40 
TITANIUM DIOXIDE 
STEARIC ACID 
CELLULOSE, MICROCRYSTALLINE 
STARCH, POTATO 
CALCIUM SULFATE 
GELATIN 
SUCROSE 
SOYBEAN OIL 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
POLYVINYL ALCOHOL 
POLYETHYLENE GLYCOLS 
FD&C YELLOW NO. 6 
FD&C BLUE NO. 1 
Product Characteristics
Colorpink (P-114, light, coated) Score no score
ShapeCAPSULE (oblong) Size19mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
Package Information Not Applicable
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/01/2009

Part 2 of 4
DHA 
doconexent and icosapent capsule, gelatin coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCONEXENT (DOCONEXENT) DOCONEXENT250 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT0.625 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
SUNFLOWER OIL 
ASCORBYL PALMITATE 
POLYSORBATE 80 
TOCOPHEROL 
Product Characteristics
ColororangeScore no score
ShapeCAPSULESize14mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
Package Information Not Applicable
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/01/2009

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN3 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE50 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN8 ug
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID120 mg
NIACIN (NIACIN) NIACIN20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID1 mg
FERROUS FUMARATE (IRON) FERROUS FUMARATE27 mg
CALCIUM CARBONATE (CARBONATE ION) CALCIUM CARBONATE200 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL410 [iU]
VITAMIN E ACETATE (VITAMIN E) VITAMIN E ACETATE30 [iU]
POTASSIUM IODIDE (IODINE) POTASSIUM IODIDE150 ug
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE15 mg
CHOLINE BITARTRATE (CHOLINE) CHOLINE BITARTRATE55 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
COLLOIDAL SILICON DIOXIDE 
MAGNESIUM STEARATE 
CITRIC ACID 
TALC 
MALTODEXTRIN 
FD&C RED NO. 40 
TITANIUM DIOXIDE 
STEARIC ACID 
CELLULOSE, MICROCRYSTALLINE 
STARCH, POTATO 
CALCIUM SULFATE 
GELATIN 
SUCROSE 
SOYBEAN OIL 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
POLYVINYL ALCOHOL 
POLYETHYLENE GLYCOLS 
FD&C YELLOW NO. 6 
FD&C BLUE NO. 1 
Product Characteristics
Colorpink (P-114, light, coated) Score no score
ShapeCAPSULE (oblong) Size19mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
Package Information Not Applicable
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/01/2009

Part 4 of 4
DHA 
doconexent and icosapent capsule, gelatin coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCONEXENT (DOCONEXENT) DOCONEXENT250 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT0.625 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
SUNFLOWER OIL 
ASCORBYL PALMITATE 
POLYSORBATE 80 
TOCOPHEROL 
Product Characteristics
ColororangeScore no score
ShapeCAPSULESize14mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
Package Information Not Applicable
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/01/2009


Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other10/01/2008

Labeler - Azur Pharma, Inc. (805611071)
Establishment
NameAddressID/FEIOperations
PureTek Corporation785961046MANUFACTURE
Establishment
NameAddressID/FEIOperations
Generic Pharmaceutical Services Inc556007078REPACK

Revised: 10/2011 Azur Pharma, Inc.