Gesticare DHA

Name: Gesticare DHA

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Gesticare DHA?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Gesticare DHA (vitamins (multiple/prenatal)) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Gesticare DHA. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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.

Adverse Reactions

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

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 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.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Black, tarry, or bloody stools.
  • Fever.
  • Very upset stomach or throwing up.
  • Very bad belly pain.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Stomach cramps.
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