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

Notes: Docosahexaenoic Acid (Form: from Algal Oil) (Alt. Name: DHA)

Forms:
  • Algal Oil
Amount: 250 mg
Serving Size: 1 Gelatin Capsule(s)

Group: DHA (Docosahexaenoic Acid)

Also known as: DHA

Amount: 0.625 mg
Serving Size: 1 Gelatin Capsule(s)

Group: EPA (Eicosapentaenoic Acid)

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

UNII Code: AAN7QOV9EA

Group: Vitamin C (ascorbyl palmitate)

EPA

fatty acid

Group: EPA (Eicosapentaenoic Acid)

Also known as: Eicosapentanoic Acid, Eicosapentaenoic Acid

Gelatin

protein

Group: Gelatin

Group: Glycerol

Group: Sunflower Oil

Group: Collagen

Also known as: Gelatin

life’s DHA

fatty acid

Group: DHA (Docosahexaenoic Acid)

Also known as: Docosahexaenoic Acid

Group: Polysorbate

Group: Vitamin E (mixed tocopherols)

UNII Code: R0ZB2556P8

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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