Label: CITRANATAL 90 DHA- vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 0178-0829-30 - Packager: Mission Pharmacal Company
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated March 25, 2013
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- BOXED WARNING (What is this?)
- KEEP OUT OF REACH OF CHILDREN
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DESCRIPTION
CitraNatal® 90 DHA 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 scored, white, oval multivitamin/mineral tablet. The tablet is debossed “CN 90” on one side and “08” bisect “29” on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture.
Each prenatal tablet contains: Vitamin C (Ascorbic acid) 120 mg Calcium (Calcium citrate) 160 mg Iron (Carbonyl iron, ferrous gluconate) 90 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) 20 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: High Oleic Sunflower Oil, Sunflower Lecithin, Rosemary Extract, Tocopherols, Ascorbyl Palmitate. - INACTIVE INGREDIENT
- PURPOSE
- 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.
WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
- PRECAUTIONS
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
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STORAGE
NOTICE: Contact with moisture can discolor or erode the tablet.
HOW SUPPLIED
Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0829-30
To report a serious adverse event or obtain product information, call (210) 696-8400.
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 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CITRANATAL 90 DHA
vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0178-0829 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE 160 mg IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 90 mg VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D 400 [iU] .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL 30 [iU] THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 3 mg RIBOPRINE (UNII: 8EU82FAZ5J) (RIBOPRINE - UNII:8EU82FAZ5J) RIBOPRINE 3.4 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 20 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg POTASSIUM TRIIODIDE (UNII: T66M6Y3KSA) (TRIIODIDE ION - UNII:DA1N05631Q) POTASSIUM TRIIODIDE 150 ug ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 mg CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 2 mg DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg Inactive Ingredients Ingredient Name Strength POVIDONES (UNII: FZ989GH94E) 152.5 mg CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 60 mg FERROUS GLUCONATE (UNII: U1B11I423Z) 44 mg TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 35.9 mg CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 30 mg NIACINAMIDE (UNII: 25X51I8RD4) 26.6 mg ACRYLIC ACID (UNII: J94PBK7X8S) 23.2 mg MAGNESIUM SILICATE (UNII: 9B9691B2N9) 11.8 mg MAGNESIUM STEARATE (UNII: 70097M6I30) 5.5 mg THIAMINE MONONITRATE (UNII: 8K0I04919X) 4.54 mg SHELLAC (UNII: 46N107B71O) 2.5 mg ETHYL VANILLIN (UNII: YC9ST449YJ) 0.4 mg VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .01 mg Product Characteristics Color BROWN (caramel) Score 2 pieces Shape CAPSULE Size 10mm Flavor Imprint Code CN;90 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0178-0829-30 6 in 1 CARTON 1 5 in 1 BLISTER PACK 1 5 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/01/2010 Labeler - Mission Pharmacal Company (008117095) Registrant - Mission Pharmacal Company (927726893) Establishment Name Address ID/FEI Business Operations Mission Pharmacal Company 927726893 MANUFACTURE(0178-0829) Establishment Name Address ID/FEI Business Operations Robinson Pharma, Inc. 831560578 MANUFACTURE(0178-0829) Establishment Name Address ID/FEI Business Operations Accucaps Industries Limited 248441727 MANUFACTURE(0178-0829)
