CitraNatal Assure: Package Insert / Prescribing Information - Drugs.com

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# CitraNatal Assure

Package insert / prescribing information
Generic name: ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent
Dosage form: capsule/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.

## CitraNatal Assure Description

CitraNatal Assure ® is a prescription prenatal/postnatal multivitamin/mineral tablet with Ferr-Ease ®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a capsule of an essential fatty acid. The prenatal vitamin is a white, coated, oval multivitamin/mineral tablet. The tablet is debossed "0891" on one side and is blank on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture.

Each prenatal capsule contains:
Vitamin C (Ascorbic acid) | 120 | mg
Calcium (Calcium citrate) | 124 | mg
Iron (Carbonyl iron, ferrous gluconate) | 35 | mg
Vitamin D 3 (Cholecalciferol) | 400 | IU
Vitamin E (dl-alpha tocopheryl acetate) | 30 | IU
Thiamin (Vitamin B 1) | 3 | mg
Riboflavin (Vitamin B 2) | 3.4 | mg
Niacinamide (Vitamin B 3) | 20 | mg
Vitamin B 6 (Pyridoxine HCl) | 25 | mg
Folic Acid | 1 | mg
Iodine (Potassium iodide) | 150 | mcg
Zinc (Zinc oxide) | 25 | mg
Copper (Cupric oxide) | 2 | mg
Docusate Sodium | 50 | mg
Each DHA gelatin capsule contains:
Docosahexaenoic Acid (DHA, 40% from 750 mg Algal Oil) | 300 | mg
Eicosapentaenoic Acid (EPA) | Not more than 0.750 | mg

Other ingredients in DHA gelatin capsule: Gelatin, sunflower oil, glycerin, caramel color, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.

## Related/similar drugs

ferrous sulfate, Prenatal Multivitamins

## INDICATIONS

CitraNatal Assure ® 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.

## 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 PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

## Warning

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

## Warning

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

## Precautions

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

## Adverse Reactions

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

## CitraNatal Assure Dosage and Administration

One tablet and one capsule daily or as directed by a physician.

CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

## STORAGE

Store at 20–25°C (68–77°F)

### NOTICE

Contact with moisture can discolor or erode the tablet.

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

51062R1120

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

All rights reserved.

Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0891-30

CitraNatal Assure Retail Blister Pack
NDC 0178–0891–30

Retail Carton

CitraNatal Assure ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent kit

Product Information
Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:0178-0891

Packaging
# | Item Code | Package Description
1 | NDC:0178-0891-30 | 30 BLISTER PACK in 1 CARTON
1 |  | 1 KIT in 1 BLISTER PACK

Quantity of Parts
Part # | Package Quantity | Total Product Quantity
Part 1 |  | 1
Part 2 |  | 1

Part 1 of 2
PRENATAL VITAMIN ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper and docusate sodium tablet, coated

Product Information
Route of Administration | ORAL | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
ASCORBIC ACID (ASCORBIC ACID) | ASCORBIC ACID | 120 mg
IRON (IRON) | IRON | 35 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) | CHOLECALCIFEROL | 400 [iU]
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) | ALPHA-TOCOPHEROL | 30 [iU]
RIBOFLAVIN (RIBOFLAVIN) | RIBOFLAVIN | 3.4 mg
NIACINAMIDE (NIACINAMIDE) | NIACINAMIDE | 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) | PYRIDOXINE HYDROCHLORIDE | 25 mg
FOLIC ACID (FOLIC ACID) | FOLIC ACID | 1 mg
IODINE (IODINE) | IODINE | 150 ug
ZINC (ZINC) | ZINC | 25 mg
COPPER (COPPER) | COPPER | 2 mg
DOCUSATE SODIUM (DOCUSATE) | DOCUSATE SODIUM | 50 mg
THIAMINE (THIAMINE ION) | THIAMINE | 3 mg
CALCIUM CITRATE (CALCIUM CATION) | CALCIUM CITRATE ANHYDROUS | 124 mg

Inactive Ingredients
Ingredient Name | Strength
POVIDONE K30 |
CROSCARMELLOSE SODIUM |
TITANIUM DIOXIDE |
MAGNESIUM SILICATE |
MAGNESIUM STEARATE |
SHELLAC |
VANILLIN |

Product Characteristics
Color | white | Score | no score
Shape | OVAL | Size | 20mm
Flavor |  | Imprint Code | 0891
Contains |

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
unapproved drug other |  | 11/19/2008 |

Part 2 of 2
DHA doconexent and icosapent capsule

Product Information
Route of Administration | ORAL | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
DOCONEXENT (DOCONEXENT) | DOCONEXENT | 300 mg
ICOSAPENT (ICOSAPENT) | ICOSAPENT | 0.75 mg

Inactive Ingredients
Ingredient Name | Strength
GELATIN |
SUNFLOWER OIL |
GLYCERIN |
LECITHIN, SUNFLOWER |
ROSEMARY |
TOCOPHEROL |
ASCORBYL PALMITATE |

Product Characteristics
Color | orange (caramel color) | Score | no score
Shape | CAPSULE | Size | 23mm
Flavor |  | Imprint Code |
Contains |

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
unapproved drug other |  | 11/19/2008 |

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
unapproved drug other |  | 04/30/2014 |

Labeler - Mission Pharmacal Company (008117095)

Registrant - Mission Pharmacal Company (927726893)

Establishment
Name | Address | ID/FEI | Operations
Mission Pharmacal Company |  | 927726893 | manufacture(0178-0891)

Mission Pharmacal Company

## More about CitraNatal Assure (multivitamin, prenatal)

- Check interactions
- Reviews (4)
- Side effects
- Dosage information
- Drug class: iron products
- En español

### Patient resources

- Patient Information

### Professional resources

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### Related treatment guides

- Vitamin/Mineral Supplementation during Pregnancy/Lactation

Medical Disclaimer

Copyright © 2020 Mission Pharmacal Company.