NDC 0178-0797 Citranatal Harmony 2.1

NDC Product Code 0178-0797

NDC CODE: 0178-0797

Proprietary Name: Citranatal Harmony 2.1 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: 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):
PURPLE (C48327 - OPAQUE)
Shape: CAPSULE (C48336)
Size(s):
25 MM
Imprint(s):
0797
Score: 1

NDC Code Structure

  • 0178 - Mission Pharmacal Company
    • 0178-0797 - Citranatal Harmony 2.1
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Citranatal Harmony 2.1 with NDC 0178-0797 is a product labeled by Mission Pharmacal Company. The generic name of Citranatal Harmony 2.1 is . The product's dosage form is and is administered via form.

Labeler Name: Mission Pharmacal Company

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.

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

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
Start Marketing Date: 01-21-2013 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: 12-31-2020 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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 Harmony 2.1 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

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.WARNINGFolic 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    mgIron (Carbonyl iron)   29 mgFolic Acid      1    mgVitamin D3 (Cholecalciferol)400 |UDocusate Sodium   50    mgVitamin 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.CAUTIONExercise 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.NOTICEContact with moisture can discolor or erode the capsule.

How Supplied

Bottles of 30 capsules each — NDC 0178–0797–30To report a serious adverse event or obtain product information, call (210) 696–8400Please consult your health care provider with any dietary concerns.Manufactured for:MISSION PHARMACAL COMPANYSan Antonio, TX USA 78230 1355

* Please review the disclaimer below.