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Gesticare DHA (Jazz Pharmaceuticals Commercial Corp.)

Available Formats

Dosage Form Package Information Links
KIT 6 BLISTER PACK in 1 CARTON (18860-253-30) > 1 KIT in 1 BLISTER PACK Label Information
KIT 6 BLISTER PACK in 1 CARTON (18860-253-00) > 1 KIT in 1 BLISTER PACK Label Information

Complete Gesticare DHA Information

  • 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

    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 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 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

    Principal Display Panel - Carton Label for Physician's Sample

  • INGREDIENTS AND APPEARANCE
    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 Item Code (Source) NDC:18860-253
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:18860-253-30 6 in 1 CARTON
    1 1 in 1 BLISTER PACK
    2 NDC:18860-253-00 6 in 1 CARTON
    2 1 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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE - UNII:X66NSO3N35) THIAMINE MONONITRATE 3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 50 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 8 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 20 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (IRON - UNII:E1UOL152H7) FERROUS FUMARATE 27 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 200 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 410 [iU]
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE 30 [iU]
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODINE - UNII:9679TC07X4) POTASSIUM IODIDE 150 ug
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15 mg
    CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y) (CHOLINE - UNII:N91BDP6H0X) CHOLINE BITARTRATE 55 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TALC (UNII: 7SEV7J4R1U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    CALCIUM SULFATE (UNII: WAT0DDB505)  
    GELATIN (UNII: 2G86QN327L)  
    SUCROSE (UNII: C151H8M554)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 250 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT 0.625 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE - UNII:X66NSO3N35) THIAMINE MONONITRATE 3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 50 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 8 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 20 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (IRON - UNII:E1UOL152H7) FERROUS FUMARATE 27 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 200 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 410 [iU]
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE 30 [iU]
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODINE - UNII:9679TC07X4) POTASSIUM IODIDE 150 ug
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15 mg
    CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y) (CHOLINE - UNII:N91BDP6H0X) CHOLINE BITARTRATE 55 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TALC (UNII: 7SEV7J4R1U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    CALCIUM SULFATE (UNII: WAT0DDB505)  
    GELATIN (UNII: 2G86QN327L)  
    SUCROSE (UNII: C151H8M554)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 250 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT 0.625 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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)