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 multi-vitamin/mineral tablet with Ferr-Ease ®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a soft gel of an essential fatty acid. The prenatal vitamin is a white, scored, oval multi-vitamin/mineral tablet. The tablet is debossed “CN 1” on one side and is blank on the other. The essential fatty acid DHA soft gel is caramel colored and contains a light yellow to orange semi-solid mixture.
Otc - Active Ingredient
| 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 |
| Other ingredients in DHA soft gel: High oleic sunflower oil, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate. | |
| Docosahexaenoic Acid (DHA, 40% from 625 mg Algal Oil) | 250 mg |
| Eicosapentaenoic Acid (EPA) | Not more than 0.625 mg |
Indications
CitraNatal ® DHA 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.
Warnings
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 B
12 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 soft gel daily or as directed by a physician.
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimalized.
NOTICE: Contact with moisture can discolor or erode the tablet.
How Supplied
Six child-resistant blister packs of 5 tablets and 5 soft gels each - NDC 0178-0894-30.
To report a serious adverse event or obtain product information, call (210) 696-8400.
Please consult your health care provider with any dietary concerns.
500243
C01 Rev 002140
DHA soft gels manufactured
for:
MISSION PHARMACAL COMPANY
San Antonio,
TX USA 78230 1355
Prenatal tablets manufactured by:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
Copyright © 2014 Mission Pharmacal
Company.
All rights reserved.
Package Label.Principal Display Panel
Citranatal
DHA
Rx Prenatal Vitamin Tablet
and 250 mg DHA
Soft Gel
Carton
NDC 0178–0894–30
Blister Pack
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