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CitraNatal Rx

Generic Name: ascorbic acid, calcium citrate, iron, vitamin d, .alpha.-tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, potassium iodide, zinc oxide and cupric oxide
Dosage Form: tablet

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.

CitraNatal® Rx

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 is CitraNatal Rx 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 
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 LABEL Item Code (Source) NDC:0178-0858
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CALCIUM CITRATE (CALCIUM CATION) CALCIUM CITRATE 124 mg
IRON (IRON) IRON 27 mg
VITAMIN D (CHOLECALCIFEROL) VITAMIN D 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 30 [iU]
THIAMINE (THIAMINE ION) THIAMINE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 150 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONES 132.2 mg
DOCUSATE SODIUM 56.1 mg
CROSCARMELLOSE SODIUM 30.6 mg
TITANIUM DIOXIDE 30.5 mg
MAGNESIUM SILICATE 10.38 mg
MAGNESIUM STEARATE 5.1 mg
SHELLAC 2.59 mg
POLYETHYLENE GLYCOLS 1.98 mg
ETHYL VANILLIN .66 mg
VITAMIN A PALMITATE .15 mg
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code CN;1
Contains         
Packaging
# Item Code Package Description
1 NDC:0178-0858-90 90 TABLET 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 Operations
Mission Pharmacal Company 927726893 MANUFACTURE(0178-0858)
Revised: 08/2014
 
Mission Pharmacal Company
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