Citranatal Harmony 2.1 description, usages, side effects, indications, overdosage, supplying and lots more!

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Citranatal Harmony 2.1

Mission Pharmacal Company
Mission Pharmacal Company

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


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

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) 104 mg Vitamin B6 (Pyridoxine HCI)    25    mg
Iron (Carbonyl iron)    29 mg Folic Acid       1    mg
Vitamin D3 (Cholecalciferol) 400 |U Docusate Sodium    50    mg
Vitamin E (d|-alpha tocopheryl acetate)    30 |U Docosahexaenoic Acid (DHA 40% from 650 mg Algal Oil) 265    mg

INDICATIONS

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.

CITRANATAL HARMONY 2.1 CONTRAINDICATIONS

This product is contraindictated 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 B12 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.

CITRANATAL HARMONY 2.1 ADVERSE REACTIONS

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.

CITRANATAL HARMONY 2.1 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.

HOW 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.




Manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355


CitraNatal Sample Carton
NDC 0178-0797-06

Citranatal Harmony 2.1

CitraNatal Label
NDC 0178-0797-05

Citranatal Harmony 2.1

CitraNatal Starter Pack

Citranatal Harmony 2.1

CitraNatal Label
NDC 0178-0797-30

Citranatal Harmony 2.1

Citranatal Harmony 2.1

Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent CAPSULE, GELATIN COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0178-0797
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CALCIUM CITRATE CALCIUM CATION 104 mg
IRON IRON 29 mg

Inactive Ingredients

Ingredient Name Strength
CHOLECALCIFEROL
.ALPHA.-TOCOPHEROL
PYRIDOXINE
FOLIC ACID
DOCUSATE SODIUM
DOCONEXENT

Product Characteristics

Color Size Imprint Code Shape
PURPLE (opaque) 25 mm 0797 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BOTTLE
2 NDC:0178-0797-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA0123456 2013-01-21


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