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

NDC Product Code 0178-0891

NDC CODE: 0178-0891

Proprietary Name: Citranatal Assure 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.

Non-Proprietary 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 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.

Product Characteristics

Color(s):
WHITE (C48325)
ORANGE (C48331 - CARAMEL COLOR)
Shape: OVAL (C48345)
CAPSULE (C48336)
Size(s):
20 MM
23 MM
Imprint(s):
0891
Score: 1

NDC Code Structure

NDC 0178-0891-10

Package Description: 5 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK

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

NDC Product Information

Citranatal Assure with NDC 0178-0891 is a 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. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1535150.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Prescription Drug 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.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • 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)
  • 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 Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mission Pharmacal Company
Labeler Code: 0178
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Start Marketing Date: 04-30-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Citranatal Assure Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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  mgCalcium (Calcium citrate)124mgIron (Carbonyl iron, ferrous gluconate)35  mgVitamin D


3 (Cholecalciferol)


400  IUVitamin E (dl-alpha tocopheryl acetate)30  IUThiamin (Vitamin B


1)


3  mgRiboflavin (Vitamin B


2)


3.4  mgNiacinamide (Vitamin B


3)


20  mgVitamin B


6 (Pyridoxine HCl)


25  mgFolic Acid1  mgIodine (Potassium iodide)150  mcgZinc (Zinc oxide)25  mgCopper (Cupric oxide)2  mgDocusate Sodium50  mgEach DHA gelatin capsule contains:Docosahexaenoic Acid (DHA, 40% from 750 mg Algal Oil)300  mgEicosapentaenoic Acid (EPA)Not more than 0.750  mgOther 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.comFerr-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.

How Supplied

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

* Please review the disclaimer below.