DHA Capsule

Basic Information

Product Label

Product label for DHA Capsule
Full Name: DHA Capsule
Brand: Gesticare
Product Type: Multi-Vitamin and Mineral (MVM)
Physical State: Capsule
UPC/SKU: 3 18860 25330 7
Product Version Code: GDHA1-11-04

Contact Information

Manufactured by

Name: PureTek Corporation
Address:San Fernando, CA, 91340
Types: Manufacturer

Distributed by

Name: Azur Pharma, Inc.
Address:1818 Market Street, Suite 2350, Philadelphia, PA, 19103
Types: Distributor

For full product information refer to

Types: Other

Product Details

Net Contents

6 Blister Card(s)(6 Blister Card(s))
30 Count(30 Count)

Serving Sizes

Unit:Gelatin Capsule(s)
Quantity:1 - 1
Daily Servings:1 - 1

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)Lactating

Ingredients & Nutrition

Group: Vitamin C

Also known as: Vitamin C

UNII Code: QN83US2B0N

Group: DHA (Docosahexaenoic Acid)

Also known as: DHA

Group: EPA (Eicosapentaenoic Acid)

Also known as: C20:5n-3, EPA

UNII Code: AAN7QOV9EA

EPA

fatty acid

Group: EPA (Eicosapentaenoic Acid)

Also known as: Eicosapentanoic Acid, Eicosapentaenoic Acid

Group: Glycerol

Group: Sunflower Oil

Group: Collagen

Hydrolyzed collagen is a form of collagen that has been broken down into smaller peptides, ensuring ease of digestion and absorption in the human body. Collagen is the most abundant protein in the body and is essential for maintaining healthy skin, bones, and connective tissues. Hydrolyzed collagen is often used as a supplement to support skin health, joint health, and overall wellness.

Also known as: Gelatin

Group: Polysorbate

Group: Vitamin E (mixed tocopherols)

Tocopherols are a class of chemical compounds of which many have vitamin E activity. They are predominant components in the group of compounds known as vitamin E, which is essential for metabolism. Their antioxidant properties protect body tissue from damage caused by free radicals, which in turn helps slow down the processes that damage cells.

Product Statements

Brand IP Statement(s) re: (c), (TM), (SM)

Gesticare(R) is a registered trademark of Azur Pharma International II Limited. life's DHA(RM) is a trademark of Martek Biosciences Corporation.

Formula re: Type

Prenatal Multi-vitamin/Mineral Tablets with DHA and Choline

Formula re: Contains

Prenatal Multi-vitamin/Mineral Tablets with DHA and Choline

General Statements: All Other Content

Not for Sale - Rx Only

Seals/Symbols

life'sDHA(TM) HEALTHY BRAIN, EYES, HEART

Formula re: Type

Indications and Usage: Gesticare(R) 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(R) DHA may be beneficial in improving the nutritional status of women prior to conception.

Precautions re: All Other

Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Precautions re: Children

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.

Precautions re: All Other

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 re: Pregnant or Nursing or Prescription Medications

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 re: All Other

Precautions: Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

Precautions re: Allergies

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

Suggested/Recommended/Usage/Directions

Dosage and Administration: One Gesticare(R) tablet and one DHA capsule daily or as directed by a physician.

General Statements: All Other Content

How Supplied: Gesticare(R) DHA is supplied as six child-resistant blister cards containing 5 Gesticare(R) tablets and 5 DHA capsules each - NDC 18860-253-30.

Precautions re: All Other

Do not use if blister seal is broken.

Precautions re: Children

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

Storage

Store at controlled room temperature 20(0)-25(0)C (68(0)-77(0)F); excursions permitted to 15(0)- 30(0)C (59(0)- 86(0)F).

General Statements: All Other Content

NDC 18860-253-30 (30 count) 6 blister cards; each containing 5 tablets and 5 capsules

Brand IP Statement(s) re: (c), (TM), (SM)

Description: Gesticare(R) DHA includes a light pink coated oblong-shaped tablet with "P-114" embossed on one side of the tablet and a natural DHA softgel capsule containing a pale orange oil.

Brand IP Statement(s) re: (c), (TM), (SM)

life'sDHA is a trademark of Martek Biosciences Corporation.

General Statements: All Other Content

GDHA1-11-03

General Statements: All Other Content

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

General Statements: All Other Content

Contains 6 Patient Starter packages, each containing 2 tablets and 2 capsules

Suggested/Recommended/Usage/Directions

One tablet and one capsule daily or as directed by physician

General: Product/Version Code

GDHA1-11-04

General Statements: All Other Content

DHA is an omega-3 fatty acid.

Brand IP Statement(s) re: (c), (TM), (SM)

The DHA in Gesticare(R) DHA is derived from Algal Oil (C.cohnii).

General Statements: All Other Content

625 mg of Algal Oil is equivalent to250 mg of DHA.

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