FDA Label for Citranatal Assure
View Indications, Usage & Precautions
Citranatal Assure Product Label
The following document was submitted to the FDA by the labeler of this product Mission Pharmacal Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 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
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.
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.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 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.
Dosage And Administration
One tablet and one capsule daily or as directed by a physician.
Storage
Store at 20–25°C (68–77°F)
Notice
Contact with moisture can discolor or erode the tablet.
Other
To report a serious adverse event or obtain product information,
call (210) 696-8400.
51062
C01 Rev 010130
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 © 2013 Mission Pharmacal Company.
All rights reserved.
www.missionpharmacal.com
Ferr-Ease®
Dual-iron delivery
Trademark of Mission Pharmacal Company
U.S. Patent No. 6,521,247
life's
DHA®
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.
How Supplied
Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0891-30
Package Label.Principal Display Panel
CitraNatal
Assure Sample Blister Pack
NDC 0178–0891–10
5-Day Sample Pack Carton
6-Count Sample Pack Display
CitraNatal
Assure Retail Blister Pack
NDC 0178–0891–30
Retail Carton
* Please review the disclaimer below.