Ferralet 90

Iron, Folic Acid, Cyanocobalamin, Ascorbic Acid, And Docusate Sodium

Mission Pharmacal Company
Human Prescription Drug
NDC 0178-0089

Ferralet 90 also known as Iron, Folic Acid, Cyanocobalamin, Ascorbic Acid, And Docusate Sodium is a human prescription drug labeled by 'Mission Pharmacal Company'. National Drug Code (NDC) number for Ferralet 90 is 0178-0089. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Ferralet 90 drug includes Ascorbic Acid - 120 mg/1 Cyanocobalamin - 12 ug/1 Docusate Sodium - 50 mg/1 Folic Acid - 1 mg/1 Iron - 90 mg/1 . The currest status of Ferralet 90 drug is Active.

Drug Information:

Drug NDC:	0178-0089
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:	Ferralet 90
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:	Iron, Folic Acid, Cyanocobalamin, Ascorbic Acid, And Docusate Sodium
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:	Tablet, Film Coated
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:	ASCORBIC ACID - 120 mg/1 CYANOCOBALAMIN - 12 ug/1 DOCUSATE SODIUM - 50 mg/1 FOLIC ACID - 1 mg/1 IRON - 90 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
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:	04 Feb, 2010
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	22 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:	836268 836270
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:	0301780089903
UPC stands for Universal Product Code.
NUI:	N0000193618 M0001797 M0022794 N0000175951
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	PQ6CK8PD0R P6YC3EG204 F05Q2T2JA0 935E97BOY8 E1UOL152H7
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.
Pharmacologic Class EPC:	Vitamin C [EPC] Vitamin B12 [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Ascorbic Acid [CS] Vitamin B 12 [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Ascorbic Acid [CS] Vitamin B 12 [CS] Vitamin B12 [EPC] Vitamin C [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
0178-0089-90	90 TABLET, FILM COATED in 1 BOTTLE (0178-0089-90)	23 Jun, 2010	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.

Other medicines with the same generic name

Ferralet 90

Iron, Folic Acid, Cyanocobalamin, Ascorbic Acid, And Docusate Sodium

Tablet, Film Coated
Mission Pharmacal Company
NDC: 0178-0089

Citranatal Bloom

Iron, Folic Acid, Cyanocobalamin, Ascorbic Acid, And Docusate Sodium

Tablet, Film Coated
Mission Pharmacal Company
NDC: 0178-0813

Product Elements:

Ferralet 90 iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium povidone croscarmellose sodium magnesium stearate fd&c yellow no. 5 magnesium silicate fd&c blue no. 1 polyethylene glycol vitamin a palmitate ethyl vanillin iron iron folic acid folic acid cyanocobalamin cyanocobalamin ascorbic acid ascorbic acid docusate sodium docusate modified f6

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 and usage ferralet Â® 90 is indicated for the treatment of all anemias that are responsive to oral iron therapy. these include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, postsurgical convalescence, and dietary needs.

Warnings:

Warning folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin b 12 is deficient.

General Precautions:

General take 2 hours after meals. do not exceed recommended dose. discontinue use if symptoms of intolerance appear. the type of anemia and underlying cause or causes should be determined before starting therapy with ferralet Â® 90 tablets. ensure hgb, hct, reticulocyte count are determined before starting therapy and periodically thereafter during prolonged treatment. periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated. this product contains fd&c yellow no. 5 (tartrazine, which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. although the overall incidence of fd&c yellow no. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Dosage and Administration:

Dosage and administration one tablet daily or as directed by a physician.

Contraindications:

Contraindications hypersensitivity to any of the ingredients. hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.

Adverse Reactions:

Adverse reactions adverse reactions with iron therapy may include gi irritation, constipation, diarrhea, nausea, vomiting, and dark stools. adverse reactions with iron therapy are usually transient. allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Pediatric Use:

Pediatric use safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

Geriatric use dosing for elderly patients should be cautious. due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.

Overdosage:

Overdosage symptoms: abdominal pain, metabolic acidosis, anuria, cns damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrohosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.

Description:

Description each green film-coated tablet for oral administration contains: iron (carbonyl iron, ferrous gluconate) 90 mg folic acid 1 1 mg vitamin b 12 (cyanocobalamin) 12 mcg vitamin c (ascorbic acid) 120 mg docusate sodium 50 50 mg inactive ingredients: povidone, croscarmellose sodium, acrylic resin, color added, magnesium stearate, fd&c yellow no. 5, magnesium silicate, fd&c blue no. 1, polyethylene glycol, vitamin a palmitate, ethyl vanillin.

Clinical Pharmacology:

Clinical pharmacology oral iron is absorbed most efficiently when administered between meals. iron is critical for normal hemoglobin synthesis to maintain oxygen transport energy production and proper function of cells. adequate amounts of iron are necessary for effective erythropoiesis. iron also serves as a cofactor of several essential enzymes, including cytochromes, which are involved in electron transport. folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. deficiency of folic acid may account for the defective deoxyribonucleic acid (dna) synthesis that leads to megaloblast formation and megaloblastic macrocytic anemias. vitamin b 12 is essential to growth, cell reproduction, hematopoiesis, nucleic acid, and myelin synthesis. deficiency may result in megalob Read more...

lastic anemia or pernicious anemia.

How Supplied:

How supplied ferralet Â® 90 (ndc 0178-0089-90) is a green, modified rectangle shaped, film-coated tablet, debossed with "f6" on one side and blank on the other, and packaged in bottles of 90. store at 25Â°c (77Â°f). excursions permitted to 15Â°-30Â°c (59Â°-86Â°f). (see usp controlled room temperature.)

Spl Patient Package Insert:

Ferralet Â® 90 90 mg dual-iron delivery rx only therapeutic guidelines for the patient some facts you should know about iron deficiency anemia iron deficiency anemia, or ida, is a common type of anemia. it's a condition in which blood lacks an adequate supply of healthy red blood cells. these cells carry oxygen to tissues. it is oxygenated blood that gives your body energy and your skin a healthy color. as the name suggests, iron deficiency anemia results from insufficient iron. your body needs iron to make a substance called hemoglobin. it's the hemoglobin in red blood cells that enables them to carry oxygen. what causes ida? there are many causes of ida. these include: a diet consistently low in iron blood loss due to heavy menstrual bleeding poor iron absorption from food due to intestinal surgery or diseases of the intestine pregnancy (when the need for iron increases significantly) women in general are at higher risk of ida, not only because they lose blood during menstruation b Read more...

ut also because their bodies store less iron. how common is it? ida is a common nutritional deficiency, with women most widely affected. up to 20% of women have ida. what are the symptoms? some of the symptoms most commonly associated with ida are fatigue, weakness, and headache. symptoms may also include light-headedness, pale skin, shortness of breath, and cold hands and feet, among others. as the body becomes more deficient in iron and anemia worsens, the symptoms worsen as well. how is ida diagnosed? a diagnosis is made primarily through blood tests. the doctor checks your hematocrit, the percentage of your blood volume made up of red blood cells and hemoglobin. a lower than normal hemoglobin level indicates anemia. also, blood tests for ida typically include a measurement of ferritin, a protein that helps store iron in your body. when the level of ferritin is low, usually the level of iron is, too. if a patient tests positive for ida, additional tests may be ordered to identify an underlying cause. does ida lead to health complications? mild cases of ida usually don't cause complications. however, left untreated, ida can increase in severity and contribute to serious health problems. for example, it may lead to a rapid or irregular heartbeat, a complicated pregnancy that can put the mother at risk for a premature delivery or low-birth-weight baby, and delayed growth in infants and children. the good news is that, because ida is easily treatable, its potential health consequences are generally avoidable. how is ida treated? it's essential to increase the amount of iron in your diet. foods rich in iron include meat, fish, poultry, and whole grain breads. however, in most cases of ida, diet alone isn't enough to correct the problem. iron supplementation is usually needed for several months. your doctor has prescribed ferralet Â® 90, a safe and effective iron supplement to help restore your body's iron to normal levels. plus, it offers the convenience of once-daily dosing. together with an iron-rich diet, taking ferralet Â® 90 every day can make a big difference in helping restore your body's iron, and with it your energy and overall feeling of well-being.

Package Label Principal Display Panel:

Principal display panel - 90 mg tablet bottle label ndc 0178-0089-90 rx only ferralet Â® 90 90 mg dual-iron delivery 90 coated tablets mission Â® pharmacal label

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.