GESTICARE DHA
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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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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.
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 |
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.
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. |
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Docosahexaenoic Acid (DHA) from Algal Oil | 250 mg |
Eicosapentaenoic Acid (EPA) | Not more than 0.625mg |
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.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.
Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
One Gesticare® tablet and one DHA capsule daily or as directed by a physician.
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).
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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.
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.
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
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
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 |
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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 |
PureTek Corporation | 785961046 | MANUFACTURE |
Establishment | |||
Name | Address | ID/FEI | Operations |
Generic Pharmaceutical Services Inc | 556007078 | REPACK |
Revised: 10/2011 Azur Pharma, Inc.