FDA Label for Citranatal Dha
View Indications, Usage & Precautions
Citranatal Dha 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® DHA is a prescription prenatal/postnatal multivitamin/mineral tablet with Ferr-Ease®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a capsule of an essential fatty acid. The prenatal vitamin is a white, scored, oval multivitamin/mineral tablet. The tablet is debossed “CN RX” on one side and is blank on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture.
| 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 |
Each DHA gelatin capsule contains:
Docosahexaenoic Acid ((DHA, 40% from 625 mg Algal Oil) 250 mg Eicosapentaenoic Acid (EPA)................. Not more than 0.625 mg Other ingredients in DHA gelatin capsule: High Oleic Sunflower Oil, Sunflower Lecithin, Rosemary Extract, Tocopherols, Ascorbyl Palmitate.
Indications
[Insert Clinical Pharmacology General text here]
Contraindications
[Insert Mechanism of Action text here]
Warning
Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.
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 and one capsule daily or as directed by a physician.
Storage
Store at 20-25°C (68-77°F)
NOTICE: Contact with moisture can discolor or erode the tablet.
How Supplied
Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0898-30
To report a serious adverse event or obtain product information, call (210) 696-8400.
500238
C01 Rev 011110
DHA capsules manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
Prenatal tablets manufactured by:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
Package Label.Principal Display Panel
CitraNatal® DHA Carton
NDC: 0178-0898-30
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