GESTICARE DHA DELAYED RELEASE
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Azur Pharma, Inc.
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Gesticare® DHADelayed-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:
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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. |
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| 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.
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 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 - 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
| GESTICARE DHA
DELAYED RELEASE
gesticare dha 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 |
| Keata Pharma Inc | 243557068 | manufacture | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Quantofill Inc. | 251273470 | manufacture | |