FDA Label for Citranatal Rx
View Indications, Usage & Precautions
Citranatal Rx Product Label
The following document was submitted to the FDA by the labeler of this product Mission Pharmacal Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
| 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.
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.
Other
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
Package Label.Principal Display Panel
CitraNatal® Rx Label
NDC: 0178-0858-90
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