Label: CITRANATAL HARMONY 2.1- 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): 0178-0797-05, 0178-0797-30 - 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 May 14, 2019
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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 “0797” in white ink.
Each prenatal capsule contains: Calcium (Calcium citrate) 104 mg Vitamin B 6 (Pyridoxine HCI) 25 mg Iron (Carbonyl iron) 29 mg Folic Acid 1 mg Vitamin D 3 (Cholecalciferol) 400 |U Docusate Sodium 50 mg Vitamin E (d|-alpha tocopheryl acetate) 30 |U Docosahexaenoic Acid (DHA 40% from 650 mg Algal Oil) 265 mg - INDICATIONS
- CONTRAINDICATIONS
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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.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient.
- PRECAUTIONS
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CITRANATAL HARMONY 2.1
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:0178-0797 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 104 mg IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 29 mg Inactive Ingredients Ingredient Name Strength CHOLECALCIFEROL (UNII: 1C6V77QF41) 400 [iU] .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 30 [iU] PYRIDOXINE (UNII: KV2JZ1BI6Z) 25 mg FOLIC ACID (UNII: 935E97BOY8) 1 mg DOCUSATE SODIUM (UNII: F05Q2T2JA0) 50 mg DOCONEXENT (UNII: ZAD9OKH9JC) 265 mg Product Characteristics Color purple (opaque) Score no score Shape CAPSULE Size 25mm Flavor Imprint Code 0797 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0178-0797-05 1 in 1 CARTON 01/21/2013 03/21/2014 1 5 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0178-0797-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2013 03/21/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/21/2013 Labeler - Mission Pharmacal Company (008117095) Registrant - Mission Pharmacal Company (927726893) Establishment Name Address ID/FEI Business Operations Accucaps Industries Limited 248441727 manufacture(0178-0797)
