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CITRANATAL ASSURE(ascorbic acid, calcium citrate, iron, vita
2015-05-13 20:52:29 来源: 作者: 【 】 浏览:456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 Assure® is a prescription prenatal/postnatal multivitamin/mineral tablet with Ferr-Ease™, a patented dual-iron delivery comprising both a quick release and slow release iron, and a capsule of an essential fatty acid. The prenatal vitamin is a white, coated, oval multivitamin/mineral tablet. The tablet is debossed "0893" on one side and is blank on the other. The essential fatty acid DHA capsule is clear and contains an amber to light/dark orange semi-solid mixture.

Each prenatal capsule contains:
Vitamin C (Ascorbic acid) 120 mg
Calcium (Calcium citrate) 125 mg
Iron (Carbonyl iron, ferrous gluconate) 35 mg
Vitamin D3 (Cholecalciferol) 400 IU
Vitamin E (dl-alpha tocopheryl acetate) 30 IU
Thiamin (Vitamin B1) 3 mg
Riboflavin (Vitamin B2) 3.4 mg
Niacinamide (Vitamin B3) 20 mg
Vitamin B6 (Pyridoxine HCl) 25 mg
Folic Acid 1 mg
Iodine (Potassium iodide) 150 mcg
Zinc (Zinc oxide) 25 mg
Copper (Cupric oxide) 2 mg
Docusate Sodium 50 mg
Each DHA gelatin capsule contains:
Docosahexaenoic Acid (DHA) 300 mg
Eicosapentaenoic Acid (EPA) Not more than 0.750 mg

DHA is contained in the oil derived from microalgae.

Other ingredients in DHA gelatin capsule: Gelatin, Glycerin USP, Water.

INDICATIONS

CitraNatal Assure® 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 tablet and one capsule daily or as directed by a physician.

Store at controlled room temperature.

NOTICE

Contact with moisture can discolor or erode the tablet.

HOW SUPPLIED

Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0893-30

To report a serious adverse event or obtain product information, call (210) 696-8400.

50289
C02 Rev 010090

Mission®
PHARMACAL

DHA capsules manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
Prenatal tablets manufactured by:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355

www.missionpharmacal.com

Copyright © 2009 Mission Pharmacal Company.

All rights reserved.

Ferr-Ease
Dual-iron delivery

Trademark of Mission Pharmacal Company
U.S. Patent No. 6,521,247

life's DHA
HEALTHY BRAIN, EYES, HEART

Trademark of Martek Biosciences Corporation
U.S. Patent No. 5,407,957
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.

PRINCIPAL DISPLAY PANEL - Six 5-day Blister Pack Carton

Rx Only
NDC
0178-0893-30

Its gentle nature
is its strength

CitraNatalAssure®

Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule

An Rx prenatal
vitamin and
omega-3 (DHA)
derived from an
all natural
plant source

march of dimes®

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

CONTAINS
Six 5-day Blister Packs

Mission®
PHARMACAL

PRINCIPAL DISPLAY PANEL - Six 5-day Blister Pack Carton

CITRANATAL ASSURE
ascorbic acid, calcium citrate, iron, vitamin d, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0178-0893
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0178-0893-30 6 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1   1 KIT ( KIT) in 1 BLISTER PACK This package is contained within the CARTON(0178-0893-30)
QUANTITY OF PARTS
Part# Package Quantity Total Product Quantity
Part1   5
Part2   5
Part 1of2
PRENATAL VITAMIN
ascorbic acid, calcium citrate, iron, vitamin d, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper and docusate sodium tablet, coated
Product Information
Route of Administration ORAL DEA Schedule  
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ascorbic acid (ascorbic acid) ascorbic acid 120mg
calcium citrate (calcium) calcium citrate 125mg
Iron (Iron ) Iron 35mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 400[iU]
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 30[iU]
Thiamine (Thiamine) Thiamine 3mg
Riboflavin (Riboflavin) Riboflavin 3.4mg
Niacinamide (Niacinamide) Niacinamide 20mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25mg
Folic Acid (Folic Acid) Folic Acid 1mg
Iodine (Iodine) Iodine 150ug
Zinc (Zinc) Zinc 25mg
Copper (Copper) Copper 2mg
Docusate Sodium (Docusate) Docusate Sodium 50mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30  
Croscarmellose Sodium  
Titanium Dioxide  
Magnesium Silicate  
Magnesium Stearate  
Shellac  
VANILLIN  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 20mm
Flavor   Imprint Code 0893
Contains  
Packaging
# Item Code Package Description Multilevel Packaging
Package Information Not Applicable
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other   11/19/2008  
Part 2of2
DHA
doconexent and icosapent capsule
Product Information
Route of Administration ORAL DEA Schedule  
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 300mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 0.75mg
Inactive Ingredients
Ingredient Name Strength
Gelatin  
Glycerin  
Water  
Product Characteristics
Color ORANGE (clear, amber to light/dark orange) Score no score
Shape CAPSULE Size 23mm
Flavor   Imprint Code  
Contains  
Packaging
# Item Code Package Description Multilevel Packaging
Package Information Not Applicable
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other   11/19/2008  

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other   11/19/2008  

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 
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