Label: CITRANATAL RX- 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): 0178-0858-90 - 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 August 4, 2014
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DESCRIPTION
CitraNatal® Rx is a prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease®, a patented dual-iron delivery comprising both a quick release and slow release iron. CitraNatal® Rx is a white, oval tablet debossed “CN 1” on one side and blank on the other.
Each prenatal tablet contains: Vitamin C (Ascorbic acid) ..............................................................................120 mg Calcium (Calcium citrate) ..............................................................................124 mg Iron (Carbonyl iron, ferrous gluconate) ..............................................................................27 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) ..............................................................................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 - INDICATIONS
- BOXED WARNING (What is this?)
- KEEP OUT OF REACH OF CHILDREN
- WARNING
- PRECAUTIONS
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- STORAGE
- NOTICE
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CITRANATAL RX
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 PRESCRIPTION DRUG Item Code (Source) NDC:0178-0858 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 124 mg IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 27 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 RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 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 IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE 150 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 mg CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 2 mg Inactive Ingredients Ingredient Name Strength POVIDONES (UNII: FZ989GH94E) 132.2 mg DOCUSATE SODIUM (UNII: F05Q2T2JA0) 56.1 mg CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 30.6 mg TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 30.5 mg MAGNESIUM SILICATE (UNII: 9B9691B2N9) 10.38 mg MAGNESIUM STEARATE (UNII: 70097M6I30) 5.1 mg SHELLAC (UNII: 46N107B71O) 2.59 mg POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) 1.98 mg ETHYL VANILLIN (UNII: YC9ST449YJ) .66 mg VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .15 mg Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code CN;1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0178-0858-90 90 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 08/11/2014 Labeler - Mission Pharmacal Company (008117095) Registrant - Mission Pharmacal Company (927726893) Establishment Name Address ID/FEI Business Operations Mission Pharmacal Company 927726893 MANUFACTURE(0178-0858)
