CitraNatal B-Calm: Package Insert / Prescribing Information - Drugs.com

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# CitraNatal B-Calm

Package insert / prescribing information
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 Oct 1, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

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

## CitraNatal B-Calm 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.

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.

## 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 6 tablets each - NDC 0178-0832-30.

To report a 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
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.

CONTAINS
Six 5-day Blister Packs

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

Packaging
# | Item Code | Package Description
1 | NDC:0178-0832-30 | 6 BLISTER PACK in 1 CARTON
1 |  | 1 KIT in 1 BLISTER PACK

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 | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) | PYRIDOXINE HYDROCHLORIDE | 25 mg
FOLIC ACID (FOLIC ACID) | FOLIC ACID | 1 mg
ASCORBIC ACID (ASCORBIC ACID) | ASCORBIC ACID | 120 mg
CALCIUM CITRATE (CALCIUM CATION) | CALCIUM CITRATE ANHYDROUS | 120 mg
IRON (IRON) | IRON | 20 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) | CHOLECALCIFEROL | 400 [iU]

Inactive Ingredients
Ingredient Name | Strength
POLYETHYLENE GLYCOL 8000 | 174.3 mg
CELLULOSE, MICROCRYSTALLINE | 55 mg
POVIDONE | 30 mg
HYPROMELLOSES | 18.9 mg
IRON PENTACARBONYL | 17.5 mg
MAGNESIUM SILICATE | 9 mg
MAGNESIUM STEARATE | 2.2 mg
VITAMIN A PALMITATE | 0.25 mg
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER |

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

Packaging
# | Item Code | Package Description
1 |  | 5 TABLET, FILM COATED in 1 BLISTER PACK

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 | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) | 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
1 |  | 10 TABLET in 1 BLISTER PACK

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 | Operations
Nutra-Med Packaging, Inc. |  | 022004902 | pack(0178-0832)

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

Mission Pharmacal Company

## More about CitraNatal B-Calm (multivitamin, prenatal)

- Check interactions
- Pricing & coupons
- Side effects
- Dosage information
- Drug class: iron products
- En español

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Medical Disclaimer

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