CITRANATAL RX- vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet 
Mission Pharmacal Company

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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CitraNatal® Rx

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

CitraNatal® Rx is a multi-vitamin/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

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.

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

STORAGE

Store at 20-25°C (68-77°F) [See USP controlled room temperature].

NOTICE

Contact with moisture can discolor or erode the tablet.

HOW SUPPLIED

Bottles of 90 tablets each - NDC 0178-0858-90.

To report a serious adverse event or obtain product information, call (210) 696-8400.


MISSION PHARMACAL COMPANY   L085890
San Antonio, TX USA 78230 1355   C01 Rev 004140

CitraNatal® Rx Label
NDC: 0178-0858-90

CitraNatal Rx 1.1 Label
CITRANATAL RX 
vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0858
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE124 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON27 mg
VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D400 [iU]
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL30 [iU]
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE20 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE150 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code CN;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0858-9090 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other08/11/2014
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
NameAddressID/FEIBusiness Operations
Mission Pharmacal Company927726893MANUFACTURE(0178-0858)

Revised: 8/2014
Document Id: c02cc80c-adb1-5582-6f60-d819a1e41748
Set id: c02cc80c-adb1-5582-6f60-d819a1e41748
Version: 1
Effective Time: 20140804
 
Mission Pharmacal Company