Drug Facts
Composition & Profile
Identifiers & Packaging
Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0891-30; CitraNatal Assure Retail Blister Pack NDC 0178–0891–30 Retail Blister; Retail Carton Label
- Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0891-30
- CitraNatal Assure Retail Blister Pack NDC 0178–0891–30 Retail Blister
- Retail Carton Label
Overview
CitraNatal Assure ® is a prescription prenatal/postnatal multivitamin/mineral tablet with Ferr-Ease ® , a patented dual-iron delivery comprising both a quick release and slow release iron, and a capsule of an essential fatty acid. The prenatal vitamin is a white, coated, oval multivitamin/mineral tablet. The tablet is debossed "0891" on one side and is blank on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture. Each prenatal capsule contains: Vitamin C (Ascorbic acid) 120 mg Calcium (Calcium citrate) 124 mg Iron (Carbonyl iron, ferrous gluconate) 35 mg Vitamin D 3 (Cholecalciferol) 400 IU Vitamin E (dl-alpha tocopheryl acetate) 30 IU Thiamin (Vitamin B 1 ) 3 mg Riboflavin (Vitamin B 2 ) 3.4 mg Niacinamide (Vitamin B 3 ) 20 mg Vitamin B 6 (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, 40% from 750 mg Algal Oil) 300 mg Eicosapentaenoic Acid (EPA) Not more than 0.750 mg Other ingredients in DHA gelatin capsule: Gelatin, sunflower oil, glycerin, caramel color, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.
Indications & Usage
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.
Dosage & Administration
One tablet and one capsule daily or as directed by a physician.
Warnings & Precautions
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 B 12 is deficient.
Boxed 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.
Contraindications
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Adverse Reactions
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Storage & Handling
STORAGE Store at 20–25°C (68–77°F) NOTICE Contact with moisture can discolor or erode the tablet.
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