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

CITRANATAL B-CALM by

Drug Labeling and Warnings

CITRANATAL B-CALM by is a Prescription medication manufactured, distributed, or labeled by Mission Pharmacal Company, Nutra-Med Packaging, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

A prescription prenatal supplement with 1 mg folic acid and a high level of vitamin B 6 which may act as an antiemetic.

DESCRIPTION

CitraNatal B-Calm ® is a prescription prenatal multivitamin/mineral tablet with B 6, along with two vitamin B 6 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 B 6 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 D 3 (Cholecalciferol)	400 IU
Vitamin B 6 (Pyridoxine HCl)	25 mg
Folic Acid	1 mg
Each vitamin B 6 tablet contains:
Vitamin B 6 (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.

BOXED WARNING

(What is this?)

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 B 12 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 B 6 tablets each - NDC 0178-0832-30.

SPL UNCLASSIFIED SECTION

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

50310 C01 Rev 008110

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 - Blister Pack Carton

Rx Only
NDC 0178-0832-30

The gentle option for
additional B 6

CitraNatalB-Calm®
Rx Prenatal Vitamin and two 25 mg each Vitamin B 6 tablets

A prescription
prenatal supplement
with 1 mg of folic
acid and a high level
of vitamin B 6 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0178-0832

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0178-0832-30	6 in 1 CARTON	06/18/2012
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CITRATE ANHYDROUS	120 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	20 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)	174.3 mg
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)	55 mg
POVIDONE (UNII: FZ989GH94E)	30 mg
HYPROMELLOSES (UNII: 3NXW29V3WO)	18.9 mg
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z)	17.5 mg
MAGNESIUM SILICATE (UNII: 9B9691B2N9)	9 mg
MAGNESIUM STEARATE (UNII: 70097M6I30)	2.2 mg
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)	0.25 mg
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	0832
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	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	Marketing Start Date	Marketing End Date
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

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	Business Operations
Nutra-Med Packaging, Inc.		080274725	pack(0178-0832)

Establishment
Name	Address	ID/FEI	Business Operations
Mission Pharmacal Company		927726893	manufacture(0178-0832)