NDC 0178-0797 Citranatal Harmony 2.1

Product Information

Product Code0178-0797
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 Harmony 2.1
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
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.
01-21-2013
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.
12-31-2020
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".
I
NDC Code Structure

Usage Information


Product Characteristics

Color(s)PURPLE (C48327 - OPAQUE)
ShapeCAPSULE (C48336)
Size(s)25 MM
Imprint(s)0797
Score1
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Citranatal Harmony 2.1 is product labeled by Mission Pharmacal Company. The product's dosage form is and is administered via form.


What are Citranatal Harmony 2.1 Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

  • CALCIUM CITRATE (UNII: MLM29U2X85)
  • CALCIUM CATION (UNII: 2M83C4R6ZB) (Active Moiety)
  • IRON (UNII: E1UOL152H7)
  • IRON (UNII: E1UOL152H7) (Active Moiety)


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.

  • CHOLECALCIFEROL (UNII: 1C6V77QF41)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • PYRIDOXINE (UNII: KV2JZ1BI6Z)
  • FOLIC ACID (UNII: 935E97BOY8)
  • DOCUSATE SODIUM (UNII: F05Q2T2JA0)
  • DOCONEXENT (UNII: ZAD9OKH9JC)


* Please review the disclaimer below.

Citranatal Harmony 2.1 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



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.

WARNING

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.


Description



CitraNatal Harmony® is a prescription prenatal/postnatal multivitamin/mineral soft gelatin capsule. The prenatal vitamin is a purple, opaque soft gelatin capsule containing a greenish-gray liquid to semi-solid fill. The capsule is printed “0797” in white ink.

Each prenatal capsule contains:
Calcium (Calcium citrate)104 mgVitamin B6 (Pyridoxine HCI)   25    mg
Iron (Carbonyl iron)   29 mgFolic Acid      1    mg
Vitamin D3 (Cholecalciferol)400 |UDocusate Sodium   50    mg
Vitamin E (d|-alpha tocopheryl acetate)   30 |UDocosahexaenoic Acid (DHA 40% from 650 mg Algal Oil)265    mg

Indications



CitraNatal Harmony® 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 contraindictated in patients with a known hypersensitivity to any of the ingredients.


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.

CAUTION

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


Dosage And Administration



One capsule daily or as directed by a physician.

Store at controlled room temperature.

NOTICE

Contact with moisture can discolor or erode the capsule.


How Supplied



Bottles of 30 capsules each — NDC 0178–0797–30

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

Please consult your health care provider with any dietary concerns.




Manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355



Package Label.Principal Display Panel



CitraNatal Sample Carton
NDC 0178-0797-06

CitraNatal Label
NDC 0178-0797-05

CitraNatal Starter Pack

CitraNatal Label
NDC 0178-0797-30


* Please review the disclaimer below.