200 mg DHA Gel Capsule

Basic Information

Product Label

Product label for 200 mg DHA Gel Capsule
Full Name: 200 mg DHA Gel Capsule
Brand: Centrix Pharmaceutical ®
Product Type: Fat/Fatty Acid
Physical State: Softgel Capsule
Status: Off Market
Product Version Code: Not Present

Contact Information

Name: Centrix Pharmaceutical, Inc.
Address:31 Inverness Center Parkway, Suite 270 , Birmingham, AL, 35242
Country: USA
Phone: 205-991-9870
Website: www.cenrx.com
Types: Manufacturer

Product Details

Net Contents

6 5-day Blister Pack(s)(6 5-day Blister Pack(s))

Serving Sizes

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

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)Lactating

Ingredients & Nutrition

Amount: 200 mg
Serving Size: 1 Softgel(s)

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

NDC 11528-095-03 Rx Only

FDA Statement of Identity

Maternal Nutritional Supplement

Formula re: Contains

An Rx Prenatal Vitamin and Omega-3 Docosahexaenoic Acid (DHA) Rx prenatal vitamin tablet and 200 mg DHA gel capsule

Formula re: Contains

Gel capsules contain a highly purified pharmaceutical grade DHA

Suggested/Recommended/Usage/Directions

Dosage and administration: One tablet and one softgel daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.

General Statements: All Other Content

How supplied: Paire OB Plus DHA is supplied in six child-resistant blister packs of 5 tablets and 5 capsules each- NDC 11528-095-03.

Precautions re: Children

Keep out of reach of children.

Storage

Storage: Store at controlled room temperature 20 degrees-25 degrees Celsius (68 degrees-77 degrees Fahrenheit). Excursions permitted to 15 degrees-30 degrees Celsius (59 degrees-86 degrees Fahrenheit).

General Statements: All Other Content

See current USP

Formulation re: Other

Contact with moisture can discolor or erode the tablet.

Formula re: Contains

Description: Paire OB Plus DHA is a prescription prenatal/postnatal multivitamin/mineral tablet and a gel capsule of an essential fatty acid.

Formulation re: Other

The essential fatty acid DHA capsule is a softgel containing a clear semi-solid mixture.

Formula re: Type

Indication and usage: Paire OB Plus DHA is a prescription multivitamin/multimineral and Omega-3 fatty acid nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in postnatal period for both lactating and non-lactating mothers. Paire OB Plus DHA is also 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. Warning: Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited of acquired predisposition to bleeding diathesis.

Formulation re: Other

The enclosed highly purified, pharmaceutical grade DHA capsules were manufactured using a 7-step refining process that meets the standards of the Global Organization for DHA Omega 3s.

General Statements: All Other Content

In child-resistant blister packaging Contains six 5-day blister packs

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