Thursday, September 1, 2016

CitraNatal CalmRx Prenatal Vitamin





Dosage Form: tablet
CitraNatal®B-Calm

Rx Prenatal Vitamin with two 25 mg each Vitamin B6 tablets

A prescription prenatal supplement with 1 mg folic acid and a high level of vitamin B6 which may act as an antiemetic.



CitraNatal CalmRx Prenatal Vitamin Description


CitraNatal® B-Calm™ is a prescription prenatal multivitamin/mineral tablet with a high level of B6, along with two vitamin B6 tablets. The prenatal tablet is white, coated, modified oval, and is debossed with "0866" on one side and is blank on the other. The B6 25 mg tablets are white to off-white, uncoated, round, and are debossed with "B" on one side and "6" on the other.


Each prenatal tablet contains:














Vitamin C (Ascorbic acid)120 mg
Calcium (Calcium citrate)125 mg
Iron (Carbonyl iron)20 mg
Vitamin D3 (Cholecalciferol)400 IU
Vitamin B6 (Pyridoxine HCl)25 mg
Folic Acid1 mg

Each vitamin B6 tablet contains:




Vitamin B6 (Pyridoxine HCl)25 mg

INDICATIONS


CitraNatal® B-Calm™ 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® B-Calm™ may be used in conjunction with a physician prescribed regimen to help minimize pregnancy related nausea and vomiting.



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 AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.




Warning


Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.



PRECAUTION


Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.



Adverse Reactions


Allergic sensitization has been reported following both oral and parenteral administration of folic acid.



CitraNatal CalmRx Prenatal Vitamin Dosage and Administration


One tablet every eight hours, beginning with "Tablet 1", or as directed by a physician.


Store at controlled room temperature.


NOTICE: Contact with moisture can discolor or erode tablets.



How is CitraNatal CalmRx Prenatal Vitamin Supplied


Six child-resistant blister packs of 5 multivitamin/multimineral tablets and 10 vitamin B6 tablets each - NDC 0178-0866-30.


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



50307 C01 REV 010090


MISSION PHARMACAL COMPANY

San Antonio, TX USA 78230 1355


www.missionpharmacal.com

Copyright © 2009 Mission Pharmacal Company.

All rights reserved.


*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


Rx Only

NDC 0178-0866-30


The gentle option for

additional B6


CitraNatal®B-Calm

Rx Prenatal Vitamin with two 25 mg each Vitamin B6 tablets


A prescription

prenatal supplement

with 1 mg of folic

acid and a high level

of vitamin B6 which

may act as an

antiemetic.


march of dimes®


Mission Pharmacal is a proud

supporter of the March of Dimes.®


CONTAINS

Six 5-day Blister Packs


Mission®

PHARMACAL
























CITRANATAL  B-CALM
ascorbic acid, calcium citrate, iron pentacarbonyl, cholecalciferol, pyridoxine hydrochloride, folic acid  kit






Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0178-0866














Packaging
#NDCPackage DescriptionMultilevel Packaging
10178-0866-305 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
11 KIT In 1 BLISTER PACKThis package is contained within the CARTON (0178-0866-30)











QUANTITY OF PARTS
Part #Package QuantityTotal Product Quantity
Part 1 
Part 2 10 



Part 1 of 2
PRENATAL VITAMIN 
ascorbic acid, calcium citrate, iron pentacarbonyl, cholecalciferol, pyridoxine hydrochloride, folic acid  tablet, coated










Product Information
   
Route of AdministrationORALDEA Schedule    























Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ascorbic acid (ascorbic acid)ascorbic acid120 mg
calcium citrate (calcium)calcium citrate125 mg
Iron Pentacarbonyl (Iron Pentacarbonyl)Iron Pentacarbonyl20 mg
Cholecalciferol (Cholecalciferol)Cholecalciferol400 [iU]
Pyridoxine Hydrochloride (Pyridoxine)Pyridoxine Hydrochloride25 mg
folic acid (folic acid)folic acid1 mg




















Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 
Cellulose, Microcrystalline 
Povidone 
Hypromelloses 
Titanium Dioxide 
Magnesium Silicate 
Magnesium Stearate 
Vitamin A Palmitate 


















Product Characteristics
ColorWHITEScoreno score
ShapeOVAL (modified)Size19mm
FlavorImprint Code0866
Contains      







Packaging
#NDCPackage DescriptionMultilevel Packaging
Package Information Not Applicable










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other02/10/2010




Part 2 of 2
VITAMIN B6 
pyridoxine hydrochloride  tablet










Product Information
   
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyridoxine Hydrochloride (Pyridoxine)Pyridoxine Hydrochloride25 mg










Inactive Ingredients
Ingredient NameStrength
Cellulose, Microcrystalline 
Povidone 
Magnesium Stearate 


















Product Characteristics
ColorWHITE (off-white)Scoreno score
ShapeROUNDSize6mm
FlavorImprint CodeB;6
Contains      







Packaging
#NDCPackage DescriptionMultilevel Packaging
Package Information Not Applicable










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other02/10/2010











Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other02/10/2010


Labeler - Mission Pharmacal Company (008117095)









Establishment
NameAddressID/FEIOperations
Mission Pharmacal Company927726893MANUFACTURE









Establishment
NameAddressID/FEIOperations
Nutra-Med Packaging Inc.022004902PACK
Revised: 05/2010Mission Pharmacal Company

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