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

CitraNatal by

Drug Labeling and Warnings

CitraNatal 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 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 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.

BOXED WARNING

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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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0178-0866

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0178-0866-30	5 in 1 CARTON
1		1 in 1 BLISTER PACK

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1		5
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 Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R)	ascorbic acid	120 mg
calcium citrate (UNII: MLM29U2X85) (calcium - UNII:SY7Q814VUP)	calcium citrate	125 mg
Iron Pentacarbonyl (UNII: 6WQ62TAQ6Z) (Iron Pentacarbonyl - UNII:6WQ62TAQ6Z)	Iron Pentacarbonyl	20 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	Cholecalciferol	400 [iU]
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine Hydrochloride	25 mg
folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8)	folic acid	1 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score	no score
Shape	OVAL (modified)	Size	19mm
Flavor		Imprint Code	0866
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		02/10/2010

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

Inactive Ingredients
Ingredient Name	Strength
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Povidone (UNII: FZ989GH94E)
Magnesium Stearate (UNII: 70097M6I30)

Product Characteristics
Color	WHITE (off-white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	B;6
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		02/10/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		02/10/2010

Labeler - Mission Pharmacal Company (008117095)

Establishment
Name	Address	ID/FEI	Business Operations
Mission Pharmacal Company		927726893	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Nutra-Med Packaging Inc.		022004902	PACK