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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.
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.
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.
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. Folic acid in doses above 0.1 mg daily may obscure
pernicious anemia in that hematologic remission can occur while neurological
manifestations progress.
Allergic sensitization
has been reported following both oral and parenteral administration
of folic acid.
One tablet
and one soft gel daily or as directed by a physician.
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.
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 1355Copyright © 2014 Mission Pharmacal
Company.
All rights reserved. Citranatal
DHA
Rx Prenatal Vitamin Tablet
and 250 mg DHA Soft Gel
CartonNDC 0178–0894–30
Blister
Pack
FDA LABEL
GENERIC: Eicosapentaenoate MFR: Mission Pharmacal Company
Dha 250 Mg / Epa 0.625 Mg Oral Capsule
Table of Contents
BOXED WARNING
DESCRIPTION
| 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
CONTRAINDICATIONS
WARNINGS
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.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient.
PRECAUTIONS
ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION
STORAGE
HOW SUPPLIED
C01 Rev 002140
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
Prenatal tablets manufactured by:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
All rights reserved.
ASK A DOCTOR
Rx Prenatal Vitamin Tablet
and 250 mg DHA Soft Gel
Carton