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
Mission Pharmacal Company
Human Prescription Drug
NDC 0178-0891Citranatal Assure also known as 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 is a human prescription drug labeled by 'Mission Pharmacal Company'. National Drug Code (NDC) number for Citranatal Assure is 0178-0891. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Citranatal Assure drug includes . The currest status of Citranatal Assure drug is Active.
Drug Information:
| Drug NDC: | 0178-0891 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Citranatal Assure |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Mission Pharmacal Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 30 Apr, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 26 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Mission Pharmacal Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1535150
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0301780891308
|
| UPC stands for Universal Product Code. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0178-0891-30 | 30 BLISTER PACK in 1 CARTON (0178-0891-30) / 1 KIT in 1 BLISTER PACK | 30 Apr, 2014 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
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 prenatal vitamin ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper and docusate sodium povidone k30 croscarmellose sodium titanium dioxide magnesium silicate magnesium stearate shellac vanillin ascorbic acid ascorbic acid iron iron cholecalciferol cholecalciferol alpha-tocopherol alpha-tocopherol riboflavin riboflavin niacinamide niacinamide pyridoxine hydrochloride pyridoxine folic acid folic acid iodine iodine zinc zinc copper copper docusate sodium docusate thiamine thiamine ion calcium citrate calcium cation calcium citrate anhydrous 0891 dha doconexent and icosapent gelatin sunflower oil glycerin lecithin, sunflower rosemary tocopherol ascorbyl palmitate doconexent doconexent icosapent icosapent caramel color
Boxed Warning:
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.
Indications and Usage:
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.
Warnings:
Warning 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 b 12 is deficient.
Dosage and Administration:
Dosage and administration one tablet and one capsule daily or as directed by a physician.
Contraindications:
Contraindications this product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Adverse Reactions:
Adverse reactions allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Description:
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) 124 mg 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 acid 1 mg iodine (potassium iodide) 150 mcg zinc (zinc oxide) 25 mg copper (cupric oxide) 2 mg docusate sodium 50 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.
How Supplied:
Six child-resistant blister packs of 5 tablets and 5 capsules each - ndc 0178-0891-30
Package Label Principal Display Panel:
Citranatal assure retail blister pack ndc 0178â0891â30 retail blister
Retail carton label