Citranatal Assure (Mission), Drug Reference Encyclopedia




Citranatal Assure (Mission)

Description

Indications and Usage

Dosage and Administration

How Supplied

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DESCRIPTION

CitraNatal� Assure is a prescription prenatal/postnatal multivitamin/mineral tablet and a capsule of an essential fatty acid. The prenatal vitamin is a white, coated, oval multivitamin/ mineral tablet. The tablet is debossed �0893� on one side and is blank on the other. The essential fatty acid DHA capsule is clear and contains an amber to light/dark orange semi-solid mixture.

Each prenatal tablet contains:

Vitamin C (Ascorbic acid) . . . . . . . . . . . . . . . . . . . . . . . . 120 mg

Calcium (Calcium citrate) . . . . . . . . . . . . . . . . . . . . . . . . 125 mg

Iron (Carbonyl iron, Ferrous gluconate) . . . . . . . . . . . . . . . 35 mg

Vitamin D3 (Cholecalciferol) . . . . . . . . . . . . . . . . . . . . . . . 400 IU

Vitamin E (dl-alpha tocopheryl acetate) . . . . . . . . . . . . . . . 30 IU

Thiamin (Vitamin B1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 mg

Riboflavin (Vitamin B2) . . . . . . . . . . . . . . . . . . . . . . . . . . .3.4 mg

Niacinamide (Vitamin B3) . . . . . . . . . . . . . . . . . . . . . . . . . 20 mg

Vitamin B6 (Pyridoxine HCl) . . . . . . . . . . . . . . . . . . . . . . . . 25 mg

Folic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 mg

Iodine (Potassium iodide) . . . . . . . . . . . . . . . . . . . . . . . 150 mcg

Zinc (Zinc oxide) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 mg

Copper (Cupric oxide) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 mg

Docusate Sodium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 mg

Each DHA gelatin capsule contains:

Docosahexaenoic Acid (DHA) . . . . . . . . . . . . . . . . . . . . . 300 mg

Calcium (Calcium citrate) . . . . . . . . . . . . . . . . . . . . . . . . 125 mg

Eicosapentaenoic Acid (EPA) . . . . . . . . Not more than 0.750 mg

DHA is contained in the oil derived from microalgae. Other ingredients in DHA gelatin capsule: Gelatin, Glycerin USP, Water.

INDICATIONS

CitraNatal Assure is a multivitamin/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.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

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.

WARNING

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

PRECAUTIONS

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

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

DOSAGE AND ADMINISTRATION

One tablet and one capsule daily or as directed by a physician. Store at controlled room temperature.

NOTICE: Contact with moisture can discolor or erode the tablet.

HOW SUPPLIED

Six child-resistant blister packs of 5 tablets and 5 capsules each�NDC 0178-0893-30

MISSION PHARMACAL COMPANY
San Antonio, TX 78230 1355

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