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CitraNatal Harmony

Mission Pharmacal Company

CitraNatal Harmony Rx Prenatal Vitamin Gel Cap


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

CITRANATAL HARMONY 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 "0799" in white ink.

Each prenatal capsule contains:

Calcium (Calcium citrate) 100 mg Vitamin B6 (Pyridoxine HCl) 25 mg
Iron (Carbonyl iron) 28 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

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 CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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

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 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 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 0178-0799-30.

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. 5,407,857
U.S. Patent No. 5,492,938

*March of Dimes does not endorse specific products or brands. March of Dimes is a registered trademark of the March of Dimes Foundation.

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

www.missionpharmacal.com

Copyright © 2011 Mission Pharmacal Company. All rights reserved.

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Carton

The one-pill solution
for gentle prenatal nutrition

Rx Only
NDC
0178-0799-05

CitraNatal Harmony ®
Rx Prenatal Vitamin Gel Cap
 

  • Convenient, one-dose prenatal nutrition
    in a vanilla-scented gel cap
     
  • Gentle calcium citrate and carbonyl iron,
    plus a stool softener and
    natural, plant-based DHA

life'sDHA ™
HEALTHY BRAIN, EYES, HEART

5-DAY STARTER PACK
In Child-Resistant Packaging
Sample–Not For Sale

Contains
Stool Softener

Working together for stronger, healthier babies

Mission®
PHARMACAL

march of dimes

Mission Pharmacal is a proud supporter of the March of Dimes.

CitraNatal Harmony

CitraNatal Harmony

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:0178-0799
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CALCIUM CITRATE CALCIUM CATION 100 mg
IRON PENTACARBONYL FERROUS CATION 28 mg
CHOLECALCIFEROL CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL, DL- 30 [iU]
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 25 mg
FOLIC ACID FOLIC ACID 1 mg
DOCUSATE SODIUM DOCUSATE 50 mg
DOCONEXENT DOCONEXENT 250 mg

Product Characteristics

Color Size Imprint Code Shape
PURPLE (opaque) 25 mm 812 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BOTTLE
2 30 in 1 BOTTLE
3 NDC:0178-0799-30 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-04-18


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