ascorbic acid, calcium citrate, iron, vitamin d, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent
Dosage Form: capsule
CitraNatalAssure®
Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule
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 "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 capsule 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 |
| 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.
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.
CitraNatal Assure 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 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.
50289
C02 Rev 010090
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
www.missionpharmacal.com
Copyright © 2009 Mission Pharmacal Company.
All rights reserved.
Ferr-Ease™
Dual-iron delivery
Trademark of Mission Pharmacal Company
U.S. Patent No. 6,521,247
life's DHA™
HEALTHY BRAIN, EYES, HEART
Trademark of Martek Biosciences Corporation
U.S. Patent No. 5,407,957
U.S. Patent No. 5,492,938
*March of Dimes does not endorse
specific products or brands.
March of Dimes is a registered trademark
of the March of Dimes Foundation.
PRINCIPAL DISPLAY PANEL - Six 5-day Blister Pack Carton
Rx Only
NDC 0178-0893-30
Its gentle nature
is its strength
CitraNatalAssure®
Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule
An Rx prenatal
vitamin and
omega-3 (DHA)
derived from an
all natural
plant source
march of dimes®
Mission Pharmacal is a proud
supporter of the March of Dimes.*
CONTAINS
Six 5-day Blister Packs
Mission®
PHARMACAL
| CitraNatal Assure ascorbic acid, calcium citrate, iron, vitamin d, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent kit | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 11/19/2008 | ||
| Labeler - Mission Pharmacal Company (008117095) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Accucaps Industries Ltd | 248441727 | MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Mission Pharmacal Company | 927726893 | MANUFACTURE | |
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