CITRANATAL DHA- vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium
Mission Pharmacal Company
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.
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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
® 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.
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 |
Each DHA soft gel contains:
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.
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.
Citranatal
DHA
Rx Prenatal Vitamin Tablet
and 250 mg DHA
Soft Gel
Carton
NDC 0178–0894–30