Active ingredientCalcium citrate, Iron pentacarbonyl, Cholecalciferol, Alpha-tocopherol, DL-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, Doconexent
Label structure12 sections
Boxed warning
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.
Dosage and administration
One capsule daily or as directed by a physician. Store at controlled room temperature. NOTICE: Contact with moisture can discolor or erode the capsule.
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 "0812" in white ink.
Each prenatal capsule contains:
Calcium (Calcium citrate)
100 mg
Vitamin B6 (Pyridoxine HCl)
25 mg
Iron (Carbonyl iron)
27 mg
Folic Acid
1 mg
Vitamin D3 (Cholecalciferol)
400 IU
Docusate Sodium
50 mg
Vitamin E (dl-alpha tocopheryl acetate)
30 IU
Docosahexaenoic Acid (DHA)
250 mg
DHA is contained in the oil derived from microalgae.
INDICATIONS
INDICATIONS & USAGE SECTION
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.
CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNING
BOXED WARNING SECTION
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.
WARNING
WARNINGS SECTION
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
WARNINGS SECTION
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
PRECAUTIONS
PRECAUTIONS SECTION
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
ADVERSE REACTIONS SECTION
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
One capsule daily or as directed by a physician.
Store at controlled room temperature.
NOTICE: Contact with moisture can discolor or erode the capsule.
HOW SUPPLIED
HOW SUPPLIED SECTION
Bottles of 30 capsules each - NDC 0178-0812-30.
SPL UNCLASSIFIED SECTION
To report a serious adverse event or obtain product information, call (210) 696-8400.
life'sDHA™
Trademark of Martek Biosciences Corporation U.S. Patent No. 5,407,957 U.S. Patent No. 5,492,938
Manufactured for: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355
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