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CitraNatal Assure Prescribing Information

Package insert / product label
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 Jan 14, 2024.

WARNING

Accidental overdose of iron-containingproducts 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.

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)124mg
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 Acid1 mg
Iodine (Potassium iodide)150 mcg
Zinc (Zinc oxide)25 mg
Copper (Cupric oxide)2 mg
Docusate Sodium50 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.

Indications and Usage for CitraNatal Assure

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.

Warnings

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.

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 progress.

Adverse Reactions/Side Effects

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 and Handling

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 Blister

LabelRetail 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0891
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0891-3030 in 1 CARTON04/30/2014
11 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
Quantity of Parts
Part #Package QuantityTotal 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON35 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL30 [iU]
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE150 ug
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC25 mg
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER2 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE ANHYDROUS124 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 (UNII: U725QWY32X)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SHELLAC (UNII: 46N107B71O)
VANILLIN (UNII: CHI530446X)
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize20mm
FlavorImprint Code0891
Contains
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/19/2008
Part 2 of 2
DHA
doconexent and icosapent capsule
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT300 mg
ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT0.75 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
ROSEMARY (UNII: IJ67X351P9)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
Product Characteristics
Colororange (caramel color) Scoreno score
ShapeCAPSULESize23mm
FlavorImprint Code
Contains
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/19/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/30/2014
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
NameAddressID/FEIBusiness Operations
Mission Pharmacal Company927726893manufacture(0178-0891)