Omega Capsule

Basic Information

Product Label

Product label for Omega Capsule
Full Name: Omega Capsule
Brand: Eckson Labs none
Product Type: Fat/Fatty Acid
Physical State: Softgel Capsule
UPC/SKU: 750-05E.01
Status: Off Market
Product Version Code: v1 Rev. 07/2013

Contact Information

Manufactured for

Name: Eckson Labs
Address:1000 N. West St., Suite 1200, #927, Wilmington, DE, 19801
Types: Distributor
Types: Other

Product Details

Net Contents

5 Daily Dose(s)(5 Daily Dose(s))

Serving Sizes

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

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)LactatingGluten Free

Ingredients & Nutrition

Notes: total Omega long-chain Fatty Acids (Form: as DHA, EPA, DPA, and ALA)

Forms:
  • and Alpha-Linolenic Acid
  • as Docosahexaenoic Acid
  • Docosapentaenoic Acid
  • Eicosapentaenoic Acid
Amount: 267 mg
Serving Size: 1 Softgel Capsule(s)

Group: Blend (Fatty Acid or Fat/Oil Supplement)

Gelatin

protein

Group: Gelatin

Group: Glycerol

Group: Collagen

Also known as: Gelatin

Group: Water

Group: Rice Oil

Product Statements

General Statements: All Other Content

Rx Only

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

when one heart becomes two(R) {heart}(R)

FDA Statement of Identity

Prescription Prenatal Vitamins

Formula re: Contains

Features an innovative blend of iron and omega long-chain fatty acids

Formula re: Contains

This unit contains 5 daily doses - NOT FOR SALE

General Statements: All Other Content

This unit contains 5 daily doses - NOT FOR SALE by Eckson Labs

Formulation re: Does NOT Contain

GLUTEN FREE & 267 mg Omegas

Formula re: Contains

GLUTEN FREE & 267 mg Omegas

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

Duet(R) DHA Balanced Starter Kit

General: Product/Version Code

v1 Rev. 07/2013

Formula re: Type

INDICATIONS: This product is a gluten-free prescription regimen of prenatal multi-vitamin, multi-mineral and omega fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers.

Formulation re: Does NOT Contain

INDICATIONS: This product is a gluten-free prescription regimen of prenatal multi-vitamin, multi-mineral and omega fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers.

General Statements: All Other Content

This product is also useful in improving the nutritional status prior to conception.

Precautions re: Allergies

CONTRAINDICATIONS: This product is contraindicated in patients with known hypersensitivity to any of the ingredients, including fish or fish oil.

Precautions re: Pregnant or Nursing or Prescription Medications

Since daily ingestion of more than 3 grams per day of omega-3 fatty acids, including ALA (alpha-linolenic acid), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.

Precautions re: Children

KEEP OUT OF REACH OF CHILDREN.

Suggested/Recommended/Usage/Directions

DOSAGE AND ADMINISTRATION: Before, during and after pregnancy, one tablet and one softgel capsule taken by mouth daily or as directed by a physician. The tablet and softgel capsule may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.

Precautions re: All Other

Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.

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

HOW SUPPLIED: A 30-day regimen supplied in a carton, NDC 44118-750-30, containing 6 child-resistant blister cards. Each blister card contains 5 maroon Duet(R) tablets (imprinted "750") and 5 softgel capsules. Tamper evident by foil seal.

Storage

STORAGE: Store at controlled room temperature 20(0) to 25(0)C (68(0) to 77(0)F), excursions permitted to 15(0) to 30(0)C (59(0) to 86(0)F). Relative humidity not to exceed 65%. Protect from moisture, excessive heat and freezing.

General Statements: All Other Content

To report a serious adverse event or obtain product information, call 1-855-899-4237.

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