CitraNatal Assure ® Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule
DESCRIPTION
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.
Other ingredients in DHA gelatin capsule: Gelatin, sunflower oil, glycerin, caramel color, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.
| 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 |
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-containingproducts 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 B 12is 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.
DOSAGE AND ADMINISTRATION
One tablet and one capsule daily or as directed by a physician.
SPL UNCLASSIFIED SECTION
CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
STORAGE
Store at 20–25°C (68–77°F)
NOTICE
Contact with moisture can discolor or erode the tablet.
SPL UNCLASSIFIED SECTION
To report a serious adverse event or obtain product information, call (210) 696-8400.
51062R1120
MISSION ®PHARMACAL
DHA capsules manufactured for: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355 Prenatal tablets manufactured by: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355
Copyright © 2020 Mission Pharmacal Company.
All rights reserved.
HOW SUPPLIED SECTION
Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0891-30
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
CitraNatal Assure Retail Blister Pack NDC 0178–0891–30
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Retail Carton