DHA Softgel Capsule

Basic Information

Product Label

Product label for DHA Softgel Capsule
Full Name: DHA Softgel Capsule
Brand: Exeltis USA none
Product Type: Fat/Fatty Acid
Physical State: Capsule
Status: Off Market
Product Version Code: 0763001-01

Contact Information

Distributed by

Name: Exeltis USA, Inc.
Address:Florham Park, NJ, 07932
Country: USA
Phone: 1-877-324-9349
Website: www.exeltisusa.com
Types: Distributor

Product Details

Net Contents

N/A(0 Not Present)

Serving Sizes

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

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)Lactating

Ingredients & Nutrition

Notes: Algal Oil Blend (Form: derived from natural Algal Oil)

Forms:
  • derived from natural Algal Oil
Amount: 486 mg
Serving Size: 0 Softgel Capsule(s)

Group: Algal Oil

Group: DHA (Docosahexaenoic Acid)

Also known as: DHA

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

Water

other

Group: Water

Product Statements

General Statements: All Other Content

0642-0076-30

FDA Statement of Identity

Prenatal Supplement with DHA Rx

General Statements: All Other Content

Composition:

Formula re: Type

Indications and usage: Vitafol-OB+DHA is indicated to provide vitamin, mineral and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish.

Formulation re: Does NOT Contain

Vitafol-OB+DHA does not contain fish, fish oils, fish proteins or fish byproducts.

Precautions re: All Other

Contraindications: Vitafol-OB+DHA is contraindicated in patients with hypersensitivity to any of its components or color additives.

Precautions re: All Other

Warnings/Precautions: Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding. Supplemental intake of omega-3 fatty acids, such as DHA exceeding 2 grams per day is not recommended. Avoid overdosage.

Precautions re: Children

Keep out of the reach of children.

Precautions re: All Other

Drug interactions: Consult appropriate references for additional specific vitamin-drug interactions.

Precautions re: Children

Pediatric use: Not for pediatric use.

Precautions re: All Other

Adverse reactions: Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol-OB+DHA.

Precautions re: Allergies

Allergic reactions have been reported with some forms of gum acacia to include respiratory problems and skin lesions.

Suggested/Recommended/Usage/Directions

Dosage and administration: Before, during and after pregnancy, one caplet and one soft-gel capsule daily, or as directed by a physician.

General Statements: All Other Content

How supplied: Vitafol-OB+DHA is available as a light blue caplet debossed EV0079 and one amber-colored DHA softgel capsule. Available in Box of Unit-Dose pack of 30 (6 child resistant blister cards of 5 caplets and 5 softgel capsules each), (0642-0076-30) and as professional samples (0642-0076-03).

Storage

Store at room temperature, approximately 15 degrees - 30 degrees C (59 degrees - 86 degrees F), avoid excessive heat and moisture.

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

2018 Exeltis USA, Inc. U.S. Patent No. 6,814,983; 7,390,509 Vitafol is a trademark of Exeltis USA, Inc.

General Statements: All Other Content

Rev. November 2018

Formula re: Contains

Vitafol-OB+DHA

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