Rx Item-ACCRUFER ferric maltol 30mg Iron 56 Capsules by Shield Therapeutics

ACCRUFER (ferric maltol) 30 mg iron capsules are supplied as 56 capsules in HDPE bottles with a child-proof polypropylene push-lock.

1 Bottle of 56-count 30 mg ferric iron capsules (NDC 73059-001-56). HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ACCRUFERTM safely and effectively. See full prescribing information for ACCRUFER.
ACCRUFER (ferric maltol) capsules, for oral use Initial U.S. Approval: 2019
-----------------------------INDICATIONS AND USAGE-------------------------- ACCRUFER is an iron replacement product indicated for the treatment of iron deficiency in adults. (1)
------------------------DOSAGE AND ADMINISTRATION---------------------- � 30 mg twice daily on an empty stomach (2.1) � Continue as long as necessary to replenish body iron stores (2.1)
---------------------DOSAGE FORMS AND STRENGTHS---------------------- Capsules: 30 mg (3) -------------------------------CONTRAINDICATIONS------------------------------ � Hypersensitivity to the active substance or any excipient (4) � Hemochromatosis and other iron overload syndromes (4) � Patients receiving repeated blood transfusions (4)






------------------------WARNINGS AND PRECAUTIONS----------------------- � IBD flare: Avoid use in patients with IBD flare (5.1) � Iron overload: Accidental overdose of iron products is a leading cause of fatal poisoning in children under 6. Keep out of reach of children. (5.2) --------------------------- ADVERSE REACTIONS------------------------------ Most common adverse reactions (incidence > 1%) are flatulence, diarrhea, constipation, feces discolored, abdominal pain, nausea, vomiting and abdominal discomfort/distension. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact [name of manufacturer] at [toll-free phone #] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
------------------------------DRUG INTERACTIONS------------------------------- � Dimercaprol: Avoid concomitant use. (7.2) � Oral Medications: Separate administration of ACCRUFER from certain oral medications. Monitor clinical responses as appropriate. (7.1, 7.2)


See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 7/2019
Reference ID: 4467971



16.2 Storage and Handling Store at 20�C to 25�C (68�F to 77�F); excursions permitted to 15�C to 30�C (59�F to 86�F) [See USP controlled room temperature].

Rx Item-ACCRUFER ferric maltol 30mg Iron
NDC No.73059-001-56 73059-0001-56 73059000156 7305900156 UPC/GTIN No.3--7305900156-5 3730590-01565 373059001565 MPN No. 156

ACCRUFER ferric maltol 30mg Ir
ACCRUFER ferric maltol 30mg Iron NDC No.73059-001-56 73059-0001-56 73059000156 7305900156 UPC/GTIN No.3--7305900156-5 3730590-01565 373059001565 MPN No. 156

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Rx Item-ACCRUFER ferric maltol 30mg Iron
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Drug info from Dailymed
Drug info from Dailymed