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

CitraNatal Rx by

Drug Labeling and Warnings

CitraNatal Rx by is a Prescription medication manufactured, distributed, or labeled by Mission Pharmacal Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOXED WARNING

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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.

• 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 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 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

PRINCIPAL DISPLAY PANEL

CitraNatal® Rx Label
NDC: 0178-0859-90

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 tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0178-0859
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	125 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
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score	2 pieces
Shape	OVAL	Size	10mm
Flavor		Imprint Code	CN;RX
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0178-0859-90	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		11/26/2007

Labeler - Mission Pharmacal Company (008117095)

Registrant - Mission Pharmacal Company (927726893)

Establishment
Name	Address	ID/FEI	Business Operations
Mission Pharmacal Company		927726893	MANUFACTURE(0178-0859)