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CitraNatal B-Calm Prescribing Information

Package insert / product label
Generic name: ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and folic acid
Dosage form: tablet
Drug classes: Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Jan 14, 2024.

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

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.

CitraNatal B-Calm 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 and Usage for CitraNatal B-Calm

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.

Warnings

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12is deficient.

Precautions

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/Side Effects

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 is CitraNatal B-Calm 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

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 Code0832
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 CodeB;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)