ACCRUFER Ferric Maltol 30 mg Capsule, 10-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Iron trivalent, oral preparations class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Ferric maltol is used to treat or prevent anemia (a lower-than-normal number of red blood cells) when the amount of iron taken in from your diet is not enough. Ferric maltol is in a class of medications called iron replacement products. It works by providing iron to help the body to produce red blood cells.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ferric Maltol — tap one for details:
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
10 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Accrufer 30 mgthis 73059-0001-10 | Shield | 10 capsules | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 10179120 ↗ | Method of use | U-2603 | Jan 6, 2035 |
| US 9802973 ↗ | Drug substance | U-2603 | Oct 23, 2035 |
| US 9248148 ↗ | Method of use | U-2603 | Mar 29, 2031 |
| Code | What it grants | Expires |
|---|---|---|
| NPP | New Patient Population | Dec 19, 2028 |
Is there a generic version of ACCRUFER 30 MG CAPSULE?
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💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 73059-0001-06 | 1 BOTTLE, PLASTIC in 1 CARTON (73059-001-06) / 6 CAPSULE in 1 BOTTLE, PLASTIC | — | — | 2021-11-01 | Discontinued by firm |
| 73059-0001-10 You're viewing this | 1 BOTTLE, PLASTIC in 1 CARTON (73059-001-10) / 10 CAPSULE in 1 BOTTLE, PLASTIC | — | — | 2022-04-01 | Active |
| 73059-0001-60 | 1 BOTTLE, PLASTIC in 1 CARTON (73059-001-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC | $10.09 / ea | $605.10 | 2021-07-01 | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 73059-0001-10?
What is the difference between NDC 73059-0001-10 and NDC 73059-0001-06?
What NDC number is used to bill for this package of ACCRUFER Ferric Maltol 30 mg Capsule?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE ACCRUFER is indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older. ACCRUFER is an iron replacement product indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 30 mg orally twice daily on an empty stomach 1 hour before or 2 hours after meals ( 2.1 ) Swallow capsules whole. Do not open, break, or chew capsules. ( 2.1 ) Continue as long as necessary to replenish body iron stores ( 2.1 )
2.1Recommended Dosage Adults and Children Aged 10 Years and Above The recommended dosage of ACCRUFER is 30 mg orally twice daily, on an empty stomach 1 hour before or 2 hours after meals. Swallow capsules whole. Do not open, break, or chew capsules.
Treatment duration will depend on the severity of iron deficiency but generally at least 12 weeks of treatment is required. The treatment should be continued as long as necessary until ferritin levels are within the normal range.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Capsules: ACCRUFER contains 30 mg iron, as ferric maltol, in red capsules printed with “30”. Capsules: 30 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS ACCRUFER is contraindicated in patients with a history of: Hypersensitivity to the active substance or to any of the excipients [see Description ( 11 )] . Reactions could include shock, clinically significant hypotension, loss of consciousness, and/or collapse. Hemochromatosis and other iron overload syndromes [see Warnings and Precautions ( 5.1 )] .
Use may result in iron overdose [see Overdosage ( 10 )]. Receiving repeated blood transfusions. Use may result in iron overload [see Warnings and Precautions ( 5.2 ) and Overdosage ( 10 )].
Hypersensitivity to the active substance or any excipient ( 4 ) Hemochromatosis and other iron overload syndromes ( 4 ) Patients receiving repeated blood transfusions ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS IBD Flare: Avoid use in patients with IBD flare ( 5.1 ) Iron Overload: Do not administer to patients with iron overload or those receiving intravenous iron. ( 5.2 ) Risk of Overdosage in Children Due to Accidental Ingestion: Keep out of reach of children. ( 5.3 )
5.1Increased Risk of Inflammatory Bowel Disease (IBD) Flare Avoid use of ACCRUFER in patients with an active inflammatory bowel disease (IBD) flare, as there is potential risk of increased inflammation in the gastrointestinal tract.
5.2Iron Overload Excessive therapy with iron products can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Do not administer ACCRUFER to patients with evidence of iron overload or patients receiving intravenous iron [see Contraindications ( 4 )] . Assess iron parameters prior to initiating ACCRUFER and monitor iron parameters while on therapy [see Overdosage ( 10 ) and Clinical Pharmacology ( 12.2 )] .
5.3Risk of Overdosage in Children Due to Accidental Ingestion Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Risk of Inflammatory Bowel Disease Flare [see Warnings and Precautions ( 5.1 )] Iron Overload [see Warnings and Precautions ( 5.2 )] 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 Shield Therapeutics Inc at 1-888-963-6267 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to ACCRUFER in 175 adult patients in the placebo-controlled phase of three randomized studies conducted in patients with anemia and quiescent inflammatory bowel disease (IBD) (Studies AEGIS 1 & 2) or non-dialysis dependent chronic kidney disease (CKD) (AEGIS 3).
The pooled patient population had a mean age of 58 years, 67.4% were female (n=118), and 81.7% (n=143) were Caucasian. Table 1 presents all adverse reactions occurring in the placebo-controlled period of the pooled randomized studies [see Clinical Studies ( 14 )] occurring at a rate of > 1% in the treated group, and for which the rate for ACCRUFER exceeds the rate for placebo. Table 1.
Adverse Reactions Reported by ≥1% of Patients Treated with ACCRUFER During Placebo-Controlled Period of Pooled Studies (Studies AEGIS1/2 and AEGIS 3) ACCRUFER 30 mg Twice Daily (N = 175) Placebo (N = 120) Body System Adverse Reaction Gastrointestinal Flatulence 4.6% 0.0% Diarrhea 4.0% 1.7% Constipation 4.0% 0.8% Feces discolored 4.0% 0.8% Abdominal pain 2.9% 2.5% Nausea 1.7% 0.8% Vomiting 1.7% 0.0% Abdominal discomfort 1.1% 0.0% Abdominal distension 1.1% 0.0% The proportion of patients who discontinued treatment due to adverse reactions during the double-blind, placebo-controlled portion of studies was 4.6% for patients taking ACCRUFER.
The most common adverse reaction leading to discontinuation of ACCRUFER in these studies was abdominal pain (1.7% of patients). Pediatric Patients with Iron Deficiency Anemia The safety profile of ACCRUFER in pediatric patients was assessed in 24 patients aged 10 to <18 years of age enrolled to the FORTIS trial and treated with ACCRUFER. Overall, the safety profile reported in pediatric patients was consistent with the safety profile reported in adult patients with iron deficiency anemia.
🔄 Drug Interactions ▾
7 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 )
7.1Effect of Other Drugs on ACCRUFER Oral Medications There are no empirical data on avoiding drug interactions between ACCRUFER and concomitant oral medications. Concomitant use of some drugs may reduce the bioavailability of iron after administration of ACCRUFER. Separate the administration of ACCRUFER from these drugs.
The duration of separation may depend on the absorption characteristics of the medication concomitantly administered, such as time to peak concentration or whether the drug is an immediate or extended release product. Monitor clinical response to ACCRUFER.
7.2Effect of ACCRUFER on Other Drugs Dimercaprol Concomitant use of iron products with dimercaprol may increase the risk of nephrotoxicity. Avoid concomitant use of ACCRUFER with dimercaprol. Oral Medications Concomitant use of ACCRUFER may decrease the bioavailability of some drugs, including mycophenolate, ethinyl estradiol, ciprofloxacin and doxycycline [see Clinical Pharmacology ( 12.3 )] .
For oral drugs where reductions in bioavailability may cause clinically significant effects on its safety or efficacy, separate the administration of ACCRUFER by at least 4 hours. Monitor clinical responses to concomitant drugs as appropriate.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary ACCRUFER is not absorbed systemically as an intact complex following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )] . In animal reproduction studies, oral administration of ferric or ferrous compounds to gravid CD1-mice and Wistar-rats during organogenesis at doses 13 to 32 times the recommended human dose resulted in no adverse developmental outcomes. An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation (see Data) .
In animal reproduction studies, oral administration of maltol to pregnant Crl: COBS-CD (SD) BR rats during organogenesis at doses 6 times the recommended human dose resulted in no adverse developmental outcomes (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.
Data Animal Data In embryofetal development studies in mice and rats, pregnant animals received oral doses of ferric or ferrous compounds (ferrous sulfate or ferric sodium pyrophosphate) of up to 160 mg/kg/day in mice, or up to 200 mg/kg/day in rats, during the period of organogenesis. Administration of ferric or ferrous compounds at doses 13 times (in mice) or 32 times (in rats) the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes. In a multigeneration reproductive and developmental study in rats, pregnant animals received oral doses of maltol of 100, 200, and 400 mg/kg/day, during the period of organogenesis.
Administration of maltol at doses 6 times the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes.
8.2Lactation Risk Summary There are no data on the presence of ACCRUFER in human milk, the effects on the breastfed child, or the effects on milk production. ACCRUFER is not absorbed systemically as an intact complex by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to ACCRUFER.
8.4Pediatric Use The safety and effectiveness of ACCRUFER for the treatment of iron deficiency have been established in pediatric patients 10 years and older. Use of ACCRUFER for this indication is supported by evidence from adequate and well-controlled studies of ACCRUFER in adults with additional data from an adequate and well-controlled study conducted in pediatric patients aged 10 years and older [ see Clinical Studies ( 14.3 )]. Safety and effectiveness of ACCRUFER have not been established in pediatric patients under 10 years.
8.5Geriatric Use Of the 295 patients in the randomized trials of ACCRUFER, 39% of patients were aged 65 and older, while 23% were aged 75 and older. No overall differences in safety or effectiveness were observed between these patients and younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE No data are available regarding overdose of ACCRUFER in patients. Acute iron ingestion of 20 mg/kg elemental iron is potentially toxic and 200- 250 mg/kg is potentially fatal. Early signs and symptoms of iron overdose may include nausea, vomiting, abdominal pain and diarrhea.
In more serious cases there may be evidence of hypoperfusion, metabolic acidosis and systemic toxicity. Dosages of ACCRUFER in excess of iron needs may lead to accumulation of iron in storage sites leading to hemosiderosis. Periodic monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognizing iron accumulation.
Do not administer ACCRUFER to patients with iron overload [ see Contraindications ( 4 ) ] . Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action ACCRUFER delivers iron for uptake across the intestinal wall and transfer to transferrin and ferritin.
12.2Pharmacodynamics ACCRUFER has been shown to increase serum iron parameters, including ferritin and transferrin saturation (TSAT) in adults and pediatric patients 10 years and older.
12.3Pharmacokinetics Adults The pharmacokinetic properties of serum iron after administration of ACCRUFER was assessed in subjects with iron deficiency (with or without anemia) following a single dose and at steady state (after 1 week) of ACCRUFER 30 mg, 60 mg, or 90 mg twice daily (1 to 3 times the approved recommended dosage). Total serum iron concentrations increase in a less than dose proportional manner with increasing ACCRUFER doses. Total serum iron peak values were reached 1.5 to 3 hours after administration of ACCRUFER, and were comparable between Day 1 and Day 8.
Pediatric Population In a pharmacokinetic substudy of the FORTIS trial [see Clinical Studies ( 14.3 )] in pediatric patients with iron-deficiency anemia, ferric maltol 15 mg or 30 mg was administered orally twice daily, for 7-10 days in children aged 10 to <18 years. After a single dose of 30 mg on Day 1, baseline-corrected serum iron reached peak concentration (C max = 119 µg/dL) at 2 hours, with a AUC 0-t of 374 h·µg/dL in children aged 12 to <18 years. After a single dose of 15 mg on Day 1, baseline-corrected serum iron reached peak concentration (C max = 40 µg/dL) at 2.1 hours, with a AUC 0-t of 60.1 h·µg/dL in children aged 10 to 11 years.
No accumulation of maltol glucuronide was observed. Absorption ACCRUFER dissociates upon uptake from the gastrointestinal tract allowing iron and maltol to be absorbed separately. Effect of Food Food has been shown to decrease the bioavailability of iron after administration of ferric maltol capsules.
Drug Interaction Studies In vitro Of the drugs screened for an interaction with ferric maltol in vitro at pH 1.2, 4.5 and 6.8, only mycophenolate and ethinyl estradiol showed any potential for interaction. Mycophenolate recovery was reduced by up to 16% at pH 1.2 but there was no interaction at pH 4.5; due to solubility issues data are not available for pH 6.8. Ethinyl estradiol recovery was reduced by up to 35% at pH 4.5; due to solubility issues data are not available for pH 1.2 and pH 6.8.
These potential oral interactions can be avoided by spacing the administration of those drugs and ACCRUFER [see Drug Interactions ( 7.2 )] . Lisinopril, metoprolol and warfarin showed no interaction at any of the 3 pH conditions and can be taken with ACCRUFER. No interaction with ferric maltol was observed for atorvastatin (pH 6.8), and norgestimate (pH 1.2) (data were not obtainable at the other pH conditions due to solubility issues).
In vivo No clinical studies evaluating the drug interaction potential of ACCRUFER have been conducted. Iron-containing preparations may decrease ciprofloxacin absorption into the bloodstream, resulting in lower serum and urine levels and reduced effectiveness. Absorption of tetracyclines including doxycycline is reported to be impaired by iron-containing preparations.
12.6Maltol Phamacokinetics Maltol is metabolized through glucuronidation (UGT1A6) and sulphation in vitro . Of the total maltol ingested, a mean of between 39.8% and 60% was excreted in the urine as maltol glucuronide. There was no clinically meaningful change in exposure of maltol or maltol glucuronide in subjects with non-dialysis dependent chronic kidney disease (eGFR of > 15 mL/min/1.73m 2 and <60 mL/min/1.73m 2 ).
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied ACCRUFER (ferric maltol) 30 mg iron capsules are supplied as 60 red capsules, printed with “30”, in HDPE bottles with a child-proof polypropylene push-lock. 1 Bottle of 60-count 30 mg ferric iron capsules (NDC 73059-001-60).
16.2Storage 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].
📋 Description ▾
11 DESCRIPTION ACCRUFER (ferric maltol) capsules, an iron replacement product for oral administration, contain 30 mg iron and 201.5 mg maltol. Ferric maltol contains iron in a stable ferric state as a complex with a trimaltol ligand. Ferric maltol is 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1) and has the molecular formula (C 6 H 5 O 3 ) 3 Fe and a molecular mass of 431.2.
Each red capsule, printed with “30”, contains colloidal anhydrous silica, crospovidone (Type A), lactose monohydrate, magnesium stearate and sodium lauryl sulfate as inactive ingredients. In addition, the capsule shell contains FD&C Blue No. 1, FD&C Red No.
40, FD&C Yellow No.6, hypromellose and titanium dioxide. The ink used for printing the marking contains Shellac, ammonium hydroxide, ethanol, iron oxide black and propylene glycol. Image 1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Administration Inform patients to take ACCRUFER as directed on an empty stomach 1 hour before or 2 hours after meals. Instruct patients on concomitant medications that should be dosed apart from ACCRUFER [see Dosage and Administration ( 2.1 ) and Drug Interactions ( 7.2 )] .
Advise patients to swallow the capsules whole and not to open, break, or chew capsules. Adverse Reactions Advise patients that ACCRUFER may cause, flatulence, diarrhea, constipation, discolored feces, abdominal pain, nausea, vomiting or abdominal bloating or discomfort. Advise patients to report severe or persistent gastrointestinal symptoms or any allergic reactions to their physician [see Adverse Reactions ( 6.1 )].
Increased Risk of IBD Flare Advise patients that they should not use ACCRUFER if they are experiencing an IBD flare [see Warnings and Precautions ( 5.1 )] . Iron Overload and Risk of Accidental Overdose in Children Inform patients to keep this product out of reach of children as accidental overdose of iron products is a leading cause of fatal poisonings in children. In case of accidental overdose, advise them to call a doctor or poison control center immediately [see Warnings and Precautions ( 5.2, 5.3 )].
Distributed by Shield Therapeutics Inc, 7-57 Wells Avenue Newton, MA, 02459