You are here: Home > Prescription(RX) Drugs > G > Gesticare Dhadelayed Release (Azur Pharma, Inc.)

Name:Gesticare Dhadelayed Release
Manufacturer:Azur Pharma, Inc.
Category:Prescription Marketed Drugs


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

GESTICARE DHA DELAYED RELEASE -     
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.

----------

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

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. This novel, delayed-release formulation has been designed to avoid interference of calcium and iron absorption by releasing these minerals at different sites within the gastro-intestinal tract. Iron is released in the stomach, while calcium is released after the tablet reaches the small intestine.

Each tablet contains:

Ingredient Dose
Vitamin B1 (Thiamin Mononitrate) 3 mg
Vitamin B2 (Riboflavin Universal) 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 D (Vitamin D3) 410 IU
Vitamin E (Vitamin E Acetate) 30 IU
Iodine (Potassium Iodide) 150 µg
Zinc (Zinc Oxide) 15 mg
Choline (Choline Bitartrate) 55 mg

Inactive Ingredients:

Croscarmellose Sodium, Colloidal Silicon Dioxide, Silicified Microcrystalline Cellulose, Magnesium Stearate, Citric Acid, Glycerol Monostearate, Triethyl Citrate, Polysorbate 80, Sodium Hydroxide, Methacrylic Acid Copolymer Dispersion, Polyacrylate Dispersion, Talc, Hypromellose, Triacetin, Polydextrose, Maltodextrin, FD&C Red #40 Aluminum Lake, Fractionated Coconut Oil, FD&C Blue #2 Aluminum Lake, Titanium Dioxide, Dextrose Monohydrate, Stearic Acid, Sodium Carboxymethylcellulose.

Each DHA gelatin capsule contains:

DHA is an omega-3 fatty acid. The DHA in Gesticare® DHA is derived from the oils of microalgae.

Other ingredients in the DHA gelatin capsule: Gelatin (bovine), Glycerine USP, High Oleic Sunflower Oil, Ascorbyl Palmitate, Tocopherols.

Ingredient Dose
Docosahexaenoic Acid (DHA) 250 mg
Eicosapentaenoic Acid (EPA) Not more than 0.625mg

Patent Status:

U.S.Patents 5,407,957 & 5,492,938. Patent application #20070128272 pending.

INDICATIONS AND USAGE

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.

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. 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® delayed-release tablet and one DHA capsule daily or as directed by a physician.

HOW SUPPLIED

Gesticare® DHA 30 count (6 Blister Cards) is supplied as six child-resistant blister cards containing 5 Gesticare® delayed-release 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).

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

RX only

Distributed by:

Azur Pharma, Inc.

1818 Market Street, Ste 2350

Philadelphia, PA 19103

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

lifes-dha-symbol

life’sDHA is a trademark of Martek Biosciences Corporation.

PRINCIPAL DISPLAY PANEL - Carton label for blister cards

Gesticare DHADelayed-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 DHADelayed-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

PRINCIPAL DISPLAY PANEL - Blister card label for physician’s sample

Gesticare DHADelayed-Release Prenatal Multi-Vitamin/Mineral Tablets
with DHA and Choline

This novel, delayed-release formulation has been designed to avoid interference of calcium and iron absorption by releasing these minerals at different sites within the gastro-intestinal tract.

Gesticare DHA is also beneficial in improving the nutritional status of
women prior to conception.

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

One Patient Starter Kit containing 2 tablets and 2 capsules.

One tablet and one capsule daily or as directed by physician

PRINCIPAL DISPLAY PANEL - Blister card label for physician’s sample

GESTICARE DHA  DELAYED RELEASE
gesticare dha kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:18860-253
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:18860-253-30 6 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 1 KIT ( KIT) in 1 BLISTER PACK This package is contained within the CARTON (18860-253-30)
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1  
Part 2  
Part 3  
Part 4  
Part 1 of 4
GESTICARE 
gesticare tablet, delayed release
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]
VITAMIN E ACETATE (VITAMIN E) VITAMIN E 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  
COLLOIDAL SILICON DIOXIDE  
MAGNESIUM STEARATE  
CITRIC ACID  
TRIETHYL CITRATE  
POLYSORBATE 80  
SODIUM HYDROXIDE  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
TALC  
HYPROMELLOSE  
TRIACETIN  
POLYDEXTROSE  
MALTODEXTRIN  
FD&C RED NO. 40  
COCONUT OIL  
FD&C BLUE NO. 2  
TITANIUM DIOXIDE  
DEXTROSE MONOHYDRATE  
STEARIC ACID  
Product Characteristics
Color pink (P-114, light, coated) Score no score
Shape CAPSULE (oblong) Size 19mm
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
Package Information Not Applicable
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 
dha 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  
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
Package Information Not Applicable
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2009

Part 3 of 4
GESTICARE 
gesticare tablet, delayed release
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]
VITAMIN E ACETATE (VITAMIN E) VITAMIN E 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  
COLLOIDAL SILICON DIOXIDE  
MAGNESIUM STEARATE  
CITRIC ACID  
TRIETHYL CITRATE  
POLYSORBATE 80  
SODIUM HYDROXIDE  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
TALC  
HYPROMELLOSE  
TRIACETIN  
POLYDEXTROSE  
MALTODEXTRIN  
FD&C RED NO. 40  
COCONUT OIL  
FD&C BLUE NO. 2  
TITANIUM DIOXIDE  
DEXTROSE MONOHYDRATE  
STEARIC ACID  
Product Characteristics
Color pink (P-114, light, coated) Score no score
Shape CAPSULE (oblong) Size 19mm
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
Package Information Not Applicable
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 
dha 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  
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
Package Information Not Applicable
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 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 - Azur Pharma, Inc. (805611071)
Establishment
Name Address ID/FEI Operations
Keata Pharma Inc 243557068 manufacture
Establishment
Name Address ID/FEI Operations
Quantofill Inc. 251273470 manufacture

Revised: 11/2009 Azur Pharma, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


Copyright © 2017 Drugsdb.eu by Dionisios Fentas || Terms of Use

Loading

Prescription Marketed Drugs Alphabetically
A| B| C| D| E| F| G| H| I| J| K| L| M| N| O| P| Q| R| S| T| U| V| W| X| Y| Z| 0-9

Categories:
Prescription(RX) Drugs
Over-the-counter (OTC) Drugs
Homeopathic Drugs
Animal Drugs
Feedback