CITRANATAL B-CALM- ascorbic acid, calcium citrate, iron pentacarbonyl, cholecalciferol, pyridoxine hydrochloride, folic acid 
Mission Pharmacal Company

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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.

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.

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 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

Chemical Structure
CITRANATAL  B-CALM
ascorbic acid, calcium citrate, iron pentacarbonyl, cholecalciferol, pyridoxine hydrochloride, folic acid kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0866
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0866-305 in 1 CARTON
11 in 1 BLISTER PACK
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R) ascorbic acid120 mg
calcium citrate (UNII: MLM29U2X85) (calcium - UNII:SY7Q814VUP) calcium citrate125 mg
Iron Pentacarbonyl (UNII: 6WQ62TAQ6Z) (Iron Pentacarbonyl - UNII:6WQ62TAQ6Z) Iron Pentacarbonyl20 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride25 mg
folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8) folic acid1 mg
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol (UNII: 3WJQ0SDW1A)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Povidone (UNII: FZ989GH94E)  
Hypromelloses (UNII: 3NXW29V3WO)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Magnesium Silicate (UNII: 9B9691B2N9)  
Magnesium Stearate (UNII: 70097M6I30)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVAL (modified) Size19mm
FlavorImprint Code 0866
Contains    
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Povidone (UNII: FZ989GH94E)  
Magnesium Stearate (UNII: 70097M6I30)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code B;6
Contains    
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/FEIBusiness Operations
Mission Pharmacal Company927726893MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Nutra-Med Packaging Inc.022004902PACK

Revised: 5/2010
Document Id: 03d6e2ba-0ef8-48ad-ab6f-959bfbabbbf7
Set id: b7846220-4137-4f1f-aea8-cd47e992a845
Version: 1
Effective Time: 20100503
 
Mission Pharmacal Company