Dosage Form: capsule, gelatin coated
CitraNatal Harmony®
Rx Prenatal Vitamin
Gel Cap
Rx Only
CitraNatal Harmony Description
CitraNatal Harmony® is a prescription prenatal/postnatal multivitamin/mineral soft gelatin capsule. The prenatal vitamin is a purple, opaque soft gelatin capsule containing a greenish-gray liquid to semi-solid fill. The capsule is printed "0798" in white ink.
Each prenatal capsule contains:
| Calcium (Calcium citrate) | 104 | mg |
| Iron (Carbonyl iron) | 30 | mg |
| Vitamin D3 (Cholecalciferol) | 400 | IU |
| Vitamin E (dl-alpha tocopheryl acetate) | 30 | IU |
| Vitamin B6 (Pyridoxine HCl) | 25 | mg |
| Folic Acid | 1 | mg |
| Docusate Sodium | 50 | mg |
| Docosahexaenoic Acid (DHA 40% from 650 mg Algal Oil) | 260 | mg |
INDICATIONS
CitraNatal Harmony® 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 Harmony Dosage and Administration
One capsule daily or as directed by a physician.
Store at controlled room temperature.
NOTICE: Contact with moisture can discolor or erode the capsule.
How is CitraNatal Harmony Supplied
Bottles of 30 capsules each - NDC 0178-0798-30.
To report a serious adverse event or obtain product information, call (210) 696-8400.
life'sDHA™
Trademark of Martek Biosciences Corporation
U.S. Patent No. 5,407,957
U.S. Patent No. 5,492,938
Manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
Copyright © 2011 Mission Pharmacal Company.
All rights reserved.
MADE IN CANADA
L079830 C01 Rev 009110
PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
NDC 0178-0798-30
Rx Only
CitraNatal Harmony®
Rx Prenatal Vitamin
Gel Cap
30 Capsules
march of dimes®
Mission Pharmacal is a proud
supporter of the March of Dimes.*
Mission®
PHARMACAL
| CitraNatal Harmony calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, and doconexent capsule, gelatin coated | ||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| UNAPPROVED DRUG OTHER | 01/15/2012 | ||
| 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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