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CitraNatal Assure 300 mg DHA Soft Gel

Product Information

Form
Softgel Capsule
Product Type
Amino acid/Protein
DSLD Entry Date
2019-09-24

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)Lactating

All Ingredients

IngredientAmount% DV
Omega-3 Fatty Acids300 mg

† Daily Value not established.

Label Statements

Formula re: Contains

Description: CitraNatal Assure is a prescription prenatal/postnatal multi vitamin/mineral tablet with Ferr-Ease, a patented dual-iron delivery comprising both a quick release and slow release iron, and a soft gel of DHA, an essential fatty acid. The prenatal vitamin is a white, coated, oval multi-vitamin/mineral tablet. The tablet is debossed “0891” on one side and is blank on the other. The essential fatty acid DHA soft gel is caramel colored and contains a light yellow to orange semi-solid mixture.

Formula re: Type

Indications: CitraNatal Assure is a multi-vitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

Precautions re: All Other

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 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: All Other

Caution: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Suggested/Recommended/Usage/Directions

Dosage and administartion: One tablet and one soft gel daily or as directed by a physician.

Storage

Storage: Store at 20(0)C to 25(0)C (68(0)F to 77(0)F), excursions permitted between 15(0)C and 30(0)C (between 59(0)F and 86(0)F). Brief exposure to temperatures up to 40(0)C (104(0)F) may be tolerated provided the mean kinetic temperature does not exceed 25(0)C (77(0)F); however, such exposure should be minimized.

General Statements: All Other Content

How supplied: Six child-resistant blister packs of 5 tablets and 5 soft gels each - NDC 0178-0891-30

Precautions re: All Other

To report a serious adverse event or obtain product information, call (800) 531-3333.

General Statements: All Other Content

Please consult your health care provider with any dietary concerns.

Supplement Facts Panel

Supplement Facts
Serving Size 1 Softgel(s)
Amount Per Serving% Daily Value*
Omega-3 Fatty Acids
300 mg

* Percent Daily Values are based on a 2,000 calorie diet.

† Daily Value not established.

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