These highlights do not include all the information needed to use CitraNatal Harmony® safely and effectively. See full prescribing information for CitraNatal Harmony®.
CitraNatal Harmony® (Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent) capsules for oral use.
Initial U.S. Approval: 2012
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 Harmony 2.1 Description
CitraNatal Harmony® is a prescription prenatal/postnatal multivitamin/mineral soft gelatin capsule. The prenatal vitamin is a purple, opaque soft gelatin capsule containing a greenish-gray liquid to semi-solid fill. The capsule is printed “0797” in white ink.
Each prenatal capsule contains:
Calcium (Calcium citrate)
Vitamin B6 (Pyridoxine HCI)
Iron (Carbonyl iron)
Vitamin D3 (Cholecalciferol)
Vitamin E (d|-alpha tocopheryl acetate)
Docosahexaenoic Acid (DHA 40% from 650 mg Algal Oil)
CitraNatal Harmony® is a multivitamin/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 contraindictated in patients with a known hypersensitivity to any of the ingredients.
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 B12 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.
Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
CitraNatal Harmony 2.1 Dosage and Administration
One capsule daily or as directed by a physician.
Store at controlled room temperature.
Contact with moisture can discolor or erode the capsule.
How is CitraNatal Harmony 2.1 Supplied
Bottles of 30 capsules each — NDC 0178–0797–30
To report a serious adverse event or obtain product information, call (210) 696–8400
Please consult your health care provider with any dietary concerns.
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
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