CitraNatal CalmRx Prenatal Vitamin

Generic Name: ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and folic acid
Dosage Form: tablet

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.

CitraNatal B-Calm®
Rx Prenatal Vitamin and two 25 mg each 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 B6, along with two vitamin B6 tablets. The prenatal tablet contains Ferr-Ease®, a patented dualiron delivery comprising both a quick release and slow release iron. The prenatal tablet is white, coated, modified oval, and is debossed with "0832" 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) 120 mg
Iron (Carbonyl iron, Ferrous gluconate) 20 mg
Vitamin D3 (Cholecalciferol) 400 IU
Vitamin B6 (Pyridoxine HCl) 25 mg
Folic Acid 1 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 0178-0832-30.

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

50310 C01 Rev 008110

Ferr-Ease®
Dual-iron delivery

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

MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355

missionpharmacal.com
Copyright © 2011 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 - Blister Pack Carton

Rx Only
NDC 0178-0832-30

The gentle option for
additional B6

CitraNatalB-Calm®
Rx Prenatal Vitamin and 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.*

Mission®
PHARMACAL

CONTAINS
Six 5-day Blister Packs

CITRANATAL B-CALM 
ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and folic acid kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0178-0832
Packaging
# Item Code Package Description
1 NDC:0178-0832-30 6 BLISTER PACK in 1 CARTON
1 1 KIT in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 6 BLISTER PACK 30 
Part 2 6 BLISTER PACK 60 
Part 1 of 2
PRENATAL VITAMIN 
ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and folic acid tablet, film 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 120 mg
Calcium citrate (Calcium) Calcium citrate 120 mg
Iron (Iron) Iron 20 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU]
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOLS 174.3 mg
CELLULOSE, MICROCRYSTALLINE 55 mg
POVIDONE 30 mg
HYPROMELLOSES 18.9 mg
IRON PENTACARBONYL 17.5 mg
MAGNESIUM SILICATE 9.0 mg
MAGNESIUM STEARATE 2.2 mg
VITAMIN A PALMITATE 0.25 mg
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code 0832
Contains         
Packaging
# Item Code Package Description
1 5 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/18/2012
Part 2 of 2
VITAMIN B6 
pyridoxine hydrochloride tablet
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code B;6
Contains         
Packaging
# Item Code Package Description
1 10 TABLET in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/18/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/18/2012
Labeler - Mission Pharmacal Company (008117095)
Establishment
Name Address ID/FEI Operations
Mission Pharmacal Company 927726893 MANUFACTURE(0178-0832)
Establishment
Name Address ID/FEI Operations
Nutra-Med Packaging, Inc. 022004902 PACK(0178-0832)
Revised: 06/2012
 
Mission Pharmacal Company
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