Omega Softgel Capsule

Basic Information

Product Label

Product label for Omega Softgel Capsule
Full Name: Omega Softgel Capsule
Brand: Eckson Labs none
Product Type: Fat/Fatty Acid
Physical State: Softgel Capsule
UPC/SKU: 3 44118 75030 4
Product Version Code: 827581 v1 Rev. 10/2017

Contact Information

Manufactured for

Name: Eckson Labs
Address:1000 N. West St. Suite 1200 #927, Wilmington, DE, 19801
Phone: 1-855-899-4237
Website: www.DuetDHA.com
Types: Distributor

Product Details

Net Contents

30 Softgel Capsule(s)(30 Softgel Capsule(s))

Serving Sizes

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

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)LactatingGluten Free

Servings Per Container

30

Ingredients & Nutrition

Amount: 267 mg
Serving Size: 1 Softgel Capsule(s)

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

Group: Alpha-Linolenic Acid

Also known as: ALA, C18:3n-3, Omega-3

UNII Code: 0RBV727H71

Group: DHA (Docosahexaenoic Acid)

Also known as: DHA

Group: Docosapentaenoic acid

Also known as: DPA

DPA

fatty acid

Group: Docosapentaenoic acid

Also known as: Docosapentaenoic Acid

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

Gelatin

protein

Group: Gelatin

Group: Glycerol

Group: Collagen

Also known as: Gelatin

life’s DHA

fatty acid

Group: DHA (Docosahexaenoic Acid)

Also known as: Docosahexaenoic Acid

Omega-3 ALA

fatty acid

Group: Alpha-Linolenic Acid

Also known as: Alpha-Linolenic Acid

Group: Rice Oil

Group: Water

UNII Code: 059QF0KO0R

Product Statements

Formula re: Contains

Each softgel capsule contains in a clear solution of 267 mg purified omega long-chain fatty acids including DHA (docosahexaenoic acid), EPA (eicosapentaenoic acid), DPA (docosapentaenoic acid) and ALA (alpha-linolenic acid):

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.

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: Other

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: All Other

Warnings: Folic acid alone in improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

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.

General Statements: All Other Content

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 tablets (imprinted "750") and 5 softgel capsules. Tamper evident by foil seal.

Storage

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

Precautions re: All Other

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

General Statements: All Other Content

Rx only

FDA Statement of Identity

Prescription Prenatal Vitamins

Formula re: Contains

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

General Statements: All Other Content

30 day supply By Eckson Labs

Formulation re: Does NOT Contain

Gluten free & 267 mg omegas

Formula re: Contains

Gluten free & 267 mg omegas

Formulation re: Does NOT Contain

Description: This product is a gluten-free prescription regimen of prenatal multi-vitamin, multi-mineral and omega fatty acids, supplied as tablets and softgel capsules.

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

Duet DHA When one heart becomes two

General Statements: All Other Content

NDC 44118-750-30

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