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CitraNatal B-Calm

Mission Pharmacal Company

CitraNatal B-Calm Rx Prenatal Vitamin and two 25 mg each B tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

CITRANATAL B-CALM 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.

CITRANATAL B-CALM CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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.

CITRANATAL B-CALM ADVERSE REACTIONS

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

CITRANATAL B-CALM 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 0178-0832-30.

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

CitraNatal B- 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

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
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:0178-0832-30 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-06-18


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