Label: 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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Contains inactivated NDC Code(s)
NDC Code(s): 0178-0798-30 - Packager: MISSION PHARMACAL COMPANY
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 18, 2012
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- SPL UNCLASSIFIED SECTION
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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
- CONTRAINDICATIONS
- BOXED WARNING (What is this?)
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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
- PRECAUTIONS
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- STORAGE AND HANDLING
- HOW SUPPLIED
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SPL UNCLASSIFIED SECTION
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. 5,492,938Manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355Copyright © 2011 Mission Pharmacal Company.
All rights reserved.MADE IN CANADA
L079830 C01 Rev 009110
- PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
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INGREDIENTS AND APPEARANCE
CITRANATAL HARMONY
calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, and doconexent capsule, gelatin coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0178-0798 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Calcium citrate (UNII: MLM29U2X85) (Calcium - UNII:SY7Q814VUP) Calcium citrate 104 mg Iron pentacarbonyl (UNII: 6WQ62TAQ6Z) (Iron - UNII:E1UOL152H7) Iron pentacarbonyl 30 mg Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 400 [iU] .Alpha.-Tocopherol, Dl- (UNII: 7QWA1RIO01) (.Alpha.-Tocopherol, Dl- - UNII:7QWA1RIO01) .Alpha.-Tocopherol, Dl- 30 [iU] Pyridoxine hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine hydrochloride 25 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium 50 mg Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent 260 mg Product Characteristics Color PURPLE (opaque) Score no score Shape CAPSULE Size 25mm Flavor Imprint Code 0798 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0178-0798-30 1 in 1 CARTON 1 30 in 1 BOTTLE 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 Business Operations Accucaps Industries Ltd. 248441727 MANUFACTURE Establishment Name Address ID/FEI Business Operations Mission Pharmacal Company 927726893 MANUFACTURE