Label: FERRAPLUS 90- docusate sodium, folic acid, carbonyl iron, cyanocobalamin, and ascorbic acid tablet, film coated
- NDC Code(s): 13811-012-90
- Packager: Trigen Laboratories, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated May 22, 2018
If you are a consumer or patient please visit this version.
- 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.
Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.Close
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
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.Close
- 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.Close
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.Close
FerraPlus 90 is a grey speckled, oval, film-coated tablet, debossed "TL012".Close
- DIRECTIONS FOR USE
One tablet daily or as directed by a physician. Do not chew tablet.Close
- HOW SUPPLIED
FerraPlus 90 is packaged in bottles of 90 tablets.
Product Code: 13811-012-90Close
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.Close
- 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
Trigen Laboratories, LLC
Bridgewater, NJ 08807
- PRINCIPAL DISPLAY PANEL
WITH 90 MG CARBONYL IRON
90 COATED TABLETS
- INGREDIENTS AND APPEARANCE
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)