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FerraPlus 90

Package insert / prescribing information
Generic name: docusate sodium, folic acid, iron, cyanocobalamin, and ascorbic acid
Dosage form: tablet, film coated
Drug classes: Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Jan 1, 2022.

SUPPLEMENT FACTS


Contraindications

Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.

Warnings

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

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 FerraPlus 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 or if a dose change is indicated.

Folic Acid: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia assessment, such that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using these products since folic acid may mask the symptoms of pernicious anemia.


Pediatric Use: Safety and effectiveness of this product have not been established in pediatric patients.


Geriatric Use: Safety and effectiveness of this product have not been established in elderly patients.

Drug Interactions

Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.

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.

Overdosage

Symptoms: Abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.

FerraPlus 90 Description

FerraPlus 90 is a grey speckled, oval, film-coated tablet, debossed "TL012".

DIRECTIONS FOR USE

One tablet daily or as directed by a physician. Do not chew tablet.

How is FerraPlus 90 Supplied

FerraPlus 90 is packaged in bottles of 90 tablets.

Product Code: 13811-012-90

STORAGE

Store at 20° - 25°C (68° - 77°F), excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Protect from moisture (contact with moisture can discolor or erode the tablet). Dispense in a tight container with a child-resistant closure.

KEEP OUT OF THE REACH OF CHILDREN.

For use on the order of a healthcare practitioner.

Call your doctor about side effects. To report side effects, call Trigen Laboratories at 1-877-482-3788 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Customer Service: 1-888-987-4436 Rev. 05/2020

Manufactured for:

Trigen Laboratories, LLC

Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL

13811-012-90

FerraPlus 90
Tablets

WITH 90 MG CARBONYL IRON

90 COATED TABLETS

TRIGEN
LABORATORIES

FerraPlus 90
docusate sodium, folic acid, carbonyl iron, cyanocobalamin, and ascorbic acid tablet, film coated
Product Information
Product Type Item Code (Source) NDC:13811-012
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
IRON PENTACARBONYL (FERROUS CATION) FERROUS CATION 90 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
POTASSIUM CITRATE ANHYDROUS
CARBOXYMETHYLCELLULOSE SODIUM
ACACIA
POVIDONE K30
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
STEARIC ACID
MAGNESIUM STEARATE
CITRIC ACID MONOHYDRATE
ICODEXTRIN
DEXTROSE
SODIUM CITRATE
LECITHIN, SOYBEAN
Product Characteristics
Color gray Score no score
Shape OVAL Size 15mm
Flavor Imprint Code TL012
Contains
Packaging
# Item Code Package Description
1 NDC:13811-012-90 90 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 09/01/2011 09/30/2022
Labeler - Trigen Laboratories, LLC (830479668)
Trigen Laboratories, LLC