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

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.

DESCRIPTION

CitraNatal® Rx is a scored white oval multivitamin/multimineral tablet. The tablet is debossed “CN RX” on one side and is blank on the other.

Each tablet contains:
Vitamin C (Ascorbic acid)120 mg
Calcium (Calcium citrate)125 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 Acid1 mg
Iodine (Potassium iodide)150 mcg
Zinc (Zinc oxide)25 mg
Copper (Cupric oxide)2 mg
Docusate Sodium50 mg

INDICATIONS

CitraNatal® Rx is a multivitamin/multimineral 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.

WARNING

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

NOTICE: Contact with moisture can produce surface discoloration or erosion of the tablet.

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. DISPENSE IN A TIGHT, LIGHT RESISTANT CONTAINER AS DEFINED BY THE USP/NF WITH A CHILD RESISTANT CLOSURE. Store at controlled room temperature.

L085990

C02 Rev 005080


MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355

CitraNatal® Rx Label
NDC: 0178-0859-90

cnrx-0508-label-ndc-0178-0859-90-c02-l085990-90cnt-cln
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:0178-0859
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 CITRATE125 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
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONES (UNII: FZ989GH94E) 132.2 mg
FERROUS GLUCONATE (UNII: U1B11I423Z) 61.7 mg
ALPHA-TOCOPHERYLQUINONE (UNII: ZO763K43XR) 35.2 mg
MAGNESIUM SILICATE (UNII: 9B9691B2N9) 10.38 mg
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) 1.98 mg
ETHYL VANILLIN (UNII: YC9ST449YJ) .66 mg
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code CN;RX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0859-9090 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other11/26/2007
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
NameAddressID/FEIBusiness Operations
Mission Pharmacal Company927726893MANUFACTURE(0178-0859)

Revised: 3/2013
Document Id: 8ee7be74-6442-5692-edab-5d8626a510dd
Set id: 8ee7be74-6442-5692-edab-5d8626a510dd
Version: 1
Effective Time: 20130321
 
Mission Pharmacal Company