NDC 0178-0864 Citranatal Essence

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 0178-0864

NDC CODE: 0178-0864

Proprietary Name: Citranatal Essence 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.

NDC Code Structure

  • 0178 - Mission Pharmacal Company

NDC 0178-0864-30

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

NDC Product Information

Citranatal Essence with NDC 0178-0864 is a a human prescription drug product labeled by Mission Pharmacal Company. The generic name of Citranatal Essence 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 oral form.

Labeler Name: Mission Pharmacal Company

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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

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: 07-07-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Citranatal Essence Product Label Images

Citranatal Essence 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 Essence™ is a prescription prenatal/postnatal multi-vitamin/ mineral tablet with Ferr-Ease®, a dual-iron delivery comprising both a quick release and slow release iron, and a soft gel of DHA, an essential fatty acid. The prenatal vitamin is a white, coated, oval multi-vitamin/mineral tablet. The tablet is debossed “0864” on one side and is blank on the other. The essential fatty acid DHA soft gel is oblong, transparent, and caramel colored.

Indications

CitraNatal Essence
TM 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.
51065R0420
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 © 2020 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 0178-0864-30

* Please review the disclaimer below.