CitraNatal Assure
Generic Name: ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent
Dosage Form: capsule/tablet
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
CitraNatal Assure 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.
| Each prenatal capsule contains: | ||
| Vitamin C (Ascorbic acid) | 120 | mg |
| Calcium (Calcium citrate) | 124 | 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, 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
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.
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.
CitraNatal Assure Dosage and Administration
One tablet and one capsule daily or as directed by a physician.
STORAGE
NOTICE
Contact with moisture can discolor or erode the tablet.
How is CitraNatal Assure Supplied
Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0893-30
To report a serious adverse event or obtain product information, call (210) 696-8400.
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 © 2013 Mission Pharmacal Company.
Trademark of Mission Pharmacal Company
U.S. Patent No. 6,521,247
life’sDHA is a trademark of DSM.
U.S. Patent No. 7,579,174
U.S. Patent No. 7,732,170
U.S. Patent No. 5,518,918
*March of Dimes does not endorse
specific products or brands.
March of Dimes is a registered trademark
of the March of Dimes Foundation.
CitraNatal Assure Sample Blister Pack
NDC 0178–0891–10
CitraNatal Assure Retail Blister Pack
NDC 0178–0891–30
| CitraNatal Assure ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent kit |
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| Labeler - Mission Pharmacal Company (008117095) |
| Registrant - Mission Pharmacal Company (927726893) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Accucaps Industries Limited | 248441727 | MANUFACTURE(0178-0891) | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Mission Pharmacal Company | 927726893 | MANUFACTURE(0178-0891) | |
More about CitraNatal Assure (multivitamin, prenatal)
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- Drug class: iron products
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