CITRANATAL B-CALM- ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and 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 and two 25 mg each B 6tablets

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

DESCRIPTION

CitraNatal B-Calm ®is a prescription prenatal multivitamin/mineral tablet with B 6, along with two vitamin B 6tablets. 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 625 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 Acid1 mg
Each vitamin B 6tablet 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.

WARNING

Accidental overdose of iron-containingproducts 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 12is 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 6tablets each - NDC0178-0832-30.

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

50310 C01 Rev 0820

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 © 2020 Mission Pharmacal Company.

All rights reserved.

PRINCIPAL DISPLAY PANEL - Blister Pack Carton

Rx Only

NDC0178-0832-30

The gentle option for additional B 6

CitraNatalB-Calm®

Rx Prenatal Vitamin and two 25 mg each Vitamin B 6tablets

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

CONTAINS

Six 5-day Blister Packs

Label

CITRANATAL B-CALM 
ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and folic acid kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0832
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0832-306 in 1 CARTON06/18/2012
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 BLISTER PACK 30 
Part 26 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE ANHYDROUS120 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON20 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeOVALSize19mm
FlavorImprint Code 0832
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/18/2012
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
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize6mm
FlavorImprint Code B;6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/18/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/18/2012
Labeler - Mission Pharmacal Company (008117095)
Establishment
NameAddressID/FEIBusiness Operations
Nutra-Med Packaging, Inc.022004902pack(0178-0832)
Establishment
NameAddressID/FEIBusiness Operations
Mission Pharmacal Company927726893manufacture(0178-0832)

Revised: 1/2024
Document Id: 0e7645b5-71a9-72fb-e063-6394a90ae398
Set id: a524c0ff-4893-4df0-aaca-7f690b2bbb13
Version: 10
Effective Time: 20240108
 
Mission Pharmacal Company