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CITRANATAL HARMONY(calcium citrate, iron pentacarbonyl, chol
2015-05-13 20:54:15 来源: 作者: 【 】 浏览:487次 评论:0

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.

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.

CONTRAINDICATIONS

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

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.

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.

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.

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.

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Carton

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 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) Calcium citrate 100mg
Iron pentacarbonyl (Iron) Iron pentacarbonyl 28mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 400[iU]
.Alpha.-tocopherol, DL- (.Alpha.-tocopherol, DL-) .Alpha.-tocopherol, DL- 30[iU]
Pyridoxine hydrochloride (Pyridoxine) Pyridoxine hydrochloride 25mg
Folic Acid (Folic Acid) Folic Acid 1mg
Docusate Sodium (Docusate) Docusate Sodium 50mg
Doconexent (Doconexent) Doconexent 250mg
Product Characteristics
Color PURPLE (opaque) Score no score
Shape CAPSULE Size 25mm
Flavor   Imprint Code 812
Contains  
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0178-0799-05 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1   5 CAPSULE, GELATIN COATED ( CAPSULE) in 1 BOTTLE This package is contained within the CARTON(0178-0799-05)
2 NDC:0178-0799-30 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
2   30 CAPSULE, GELATIN COATED ( CAPSULE) in 1 BOTTLE This package is contained within the CARTON(0178-0799-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other   04/18/2011  

Labeler -MISSION PHARMACAL COMPANY (008117095)
Establishment
Name Address ID/FEI Operations
Accucaps Industries Ltd.   248441727 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Mission Pharmacal Company   927726893 MANUFACTURE 
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