NDC 0178-0891 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

Citranatal Assure is a human prescription drug product labeled by Mission Pharmacal Company. The generic name of Citranatal Assure is 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. The product's dosage form is kit and is administered via form.

Product Code0178-0891
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Citranatal Assure
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
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
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormKit - A packaged collection of related material.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Mission Pharmacal Company
Labeler Code0178
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
UNAPPROVED DRUG OTHER -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-30-2014
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Citranatal Assure?


Product Characteristics

Color(s)WHITE (C48325)
ORANGE (C48331 - CARAMEL COLOR)
ShapeOVAL (C48345)
CAPSULE (C48336)
Size(s)20 MM
23 MM
Imprint(s)0891
Score1

Product Packages

NDC 0178-0891-30

Package Description: 30 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK

Price per Unit: $2.02408 per EA

Product Details

Citranatal Assure Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:
  • RxCUI: 1535150 - docosaenoic acid 300 MG / eicosapentaenoic acid 0.75 MG Oral Capsule

Citranatal Assure Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

* Please review the disclaimer below.

Citranatal Assure Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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



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.

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.

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.


Dosage And Administration



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


Storage



Store at 20–25°C (68–77°F)


Notice



Contact with moisture can discolor or erode the tablet.


Other



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

51062
C01 Rev 010130

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

Copyright © 2013 Mission Pharmacal Company.

All rights reserved.

www.missionpharmacal.com

Ferr-Ease®
Dual-iron delivery

Trademark of Mission Pharmacal Company
U.S. Patent No. 6,521,247

life's DHA®

life’sDHA is a trademark of DSM.
U.S. Patent No. 7,579,174
U.S. Patent No. 7,732,170
U.S. Patent No. 5,518,918

*March of Dimes does not endorse
specific products or brands.
March of Dimes is a registered trademark
of the March of Dimes Foundation.


Package Label.Principal Display Panel



CitraNatal Assure Sample Blister Pack
NDC 0178–0891–10

5-Day Sample Pack Carton

6-Count Sample Pack Display

CitraNatal Assure Retail Blister Pack
NDC 0178–0891–30

Retail Carton


* Please review the disclaimer below.