FERRAPLUS 90- docusate sodium, folic acid, carbonyl iron, cyanocobalamin, and ascorbic acid tablet, film coated

FerraPlus 90 by

Drug Labeling and Warnings

FerraPlus 90 by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPPLEMENT FACTS

FerraPlus 90 is an Iron Supplement Multivitamin/Mineral indicated for the distinctive nutritional requirements of persons being treated for iron deficiencies by a physician. THIS PRODUCT IS NOT INDICATED FOR USE IN CHILDREN.

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.

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 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.

HEALTH CLAIM

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 1-888-9-TRIGEN (1-888-987-4436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Customer Service: 1-888-987-4436                                                                                                            Rev. 07/2018

 

 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

INGREDIENTS AND APPEARANCE

FERRAPLUS 90 
docusate sodium, folic acid, carbonyl iron, cyanocobalamin, and ascorbic acid tablet, film coated

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:13811-012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	90 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ACACIA (UNII: 5C5403N26O)
POVIDONE K30 (UNII: U725QWY32X)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ICODEXTRIN (UNII: 2NX48Z0A9G)
DEXTROSE (UNII: IY9XDZ35W2)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:13811-012-90	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		09/01/2011

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
imprint
scoring	1
shape
size (solid drugs)	15 mm

Labeler - Trigen Laboratories, LLC (830479668)