Indications and uses
Myferon 150 is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.
Myferon 150
- Manufacturer
- MARTIN EKWEALOR PHARMACEUTICALS, INC.
- Effective date
- 2014-02-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:38:38
Label at a glance#
ProductMyferon 150
Active ingredientIRON SUCROSE
Label structure15 sections
Dosage and administration
One or two capsules daily or as prescribed by a physician.
Label contents#
Full prescribing information#
SUPPLEMENTAL FACTS
Serving Size: 1 Capsule
Amount Per Serving % Daily Value
Iron (Elemental) 150 mg 833%
(As Polysaccharide Iron Complex)
INDICATIONS:
prevention and treatment of iron deficiency and/or other nutritional megaloblastic anemias
WARNING: Keep this product out of reach of children.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
INDICATIONS AND USAGE:
Myferon 150 is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.
WARNING:
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
DOSAGE AND ADMINISTRATION:
One or two capsules daily or as prescribed by a physician.
Inactive Ingredients OTHER INGREDIENTS:
D and C Red #7, D and C Red #28, D and C Yellow #10, FD and C Blue #1, FD and C Red #40, FD and C Yellow #6, Gelatin, Pharmaceutical Glaze, Sodium Lauryl Sulfate, Titanium Dioxide, Dicalcium Phosphate.
DESCRIPTION:
Myferon 150, Polysaccharide Iron Complex capsules are a preparation of ferric Iron complexed to a low molecular weight polysaccharide. This polysaccharide is obtained by extensive hydrolysis of starch.
Myferon 150 is a dark brown powder that when dissolved in water, forms a very dark brown solution. As an organic complex, polysaccharide iron contains no free iron. It is tasteless, odorless and readily soluble in water.
CLINICAL PHARMACOLOGY:
Iron is an essential compound in the formation of hemoglobin. Adequate amounts of iron are necessary for the effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes that are involved in electron transport.
A radioiscope tracer study in man demonstrated that absorption of a polysacchride-iron is comparable to that of ferrous sulfate. Clinical studies demonstrate that polysaccharide-iron produces good hematological response shown by increases in hemoglobin and hematocrit in children and adult patients. Polysaccharide-iron is effective in maintaining the hematopoietic status in end-stage kidney disease patients receiving epoetin alfa therapy.
CONTRAINDICATIONS:
Myferon 150 is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to iron therapy.
PRECAUTIONS:
The type of anemia and the underlying cause or causes should be determined before initiating treatment with Myferon 150. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected if possible. As with all oral iron preparations, Myferon 150 should be stored out of the reach of children to protect against accidental iron poisoning. Patients should not exceed the recommended dosage unless directed by a physician. Patients should be informed that iron products can cause dark or black stools.
ADVERSE REACTIONS:
Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stool and abdominal pain. Adverse reactions with iron are usually transient.
OVERDOSE:
The clinical cause of acute iron overdose can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.
Chronic toxicity studies in rats and dogs administered polysaccharide-iron complex showed that a daily dosage of 250 mg iron/kg for three months has no adverse effects. The Oral LD 50 of polysaccharide-iron complex was estimated to be greater than 5000 mg. iron/kg in rats.
HOW SUPPLIED:
Myferon 150 capsules are supplied in unit dose blister packs, 10 capsules per card, orange/brown capsules.
Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F). See USP controlled room temperature.
Myferon 150 Product Label
M.E. PHARMACEUTICALS, Inc.
58607-111-85
Myferon™ 150
Polysaccharide Iron Complex Capsules
150 mg of elemental iron
Well tolerated
Well absorbed
100 Unit Dose Capsules
Mfg by M.E. Pharmaceuticals, Inc.
Richmond, IN 47374 USA
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| FERRIC CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 04cdd491-d111-4bc2-9549-75c575e1bd4b | Product name | 1 | 20200714 |
| 8390fb8b-6c75-416c-a9a1-70e8ed493b73 | Product name | 1 | 20200611 |
| 96a528e9-23e2-495f-81b9-ae87df2f7552 | Product name | 1 | 20191120 |
| 3df56c93-5837-4523-aac2-4b1ec48b9676 | Product name | 2 | 20160719 |
| a883b7cc-d320-41d7-92ae-c873457ae641 | Product name | 1 | 20151116 |
| bb23e78e-9e64-4037-a1c1-0e1d8762700e | Product name | 1 | 20150325 |
| ef06c001-572c-d95e-42f6-ee83da75673a | Product name | 1 | 20140508 |
| fd21f957-6863-d07b-5a35-250186878716 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58607-111-85 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4344-60a7-e053-dbdaa90a05bd | c672cb8e-05a2-4ff5-b3bb-47acd955c2d9 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58607-111-85 | Myferon 150 | 100 in 1 BOX | CAPSULE | 100 | 1 | |
| 58607-111-85 | Myferon 150 | 10 in 1 BLISTER PACK | CAPSULE | 10 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58607-111-85 | EA - Each | 58607-111 | 87762c48-c0e5-4b04-af21-2674e7b45f89 | 1 | 2014-04-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IRON SUCROSE | ACTIVE INGREDIENT | FZ7NYF5N8L | 1 | |
| FERRIC CATION | ACTIVE MOIETY | 91O4LML611 | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | 1 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | 1 | |
| D&C RED NO. 7 | INACTIVE INGREDIENT | ECW0LZ41X8 | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Myferon 150
- IRON SUCROSE
- FERRIC CATION
- D&C RED NO. 7
- D&C RED NO. 28
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- SHELLAC
- SODIUM LAURYL SULFATE
- TITANIUM DIOXIDE
- CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58607-111 | 58607-111-85 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IRON SUCROSE | FZ7NYF5N8L | ACTIM |
| D&C RED NO. 7 | ECW0LZ41X8 | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| SHELLAC | 46N107B71O | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | L11K75P92J | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | GUM, CHEWING / ORAL | 2 mg | ||
| D&C RED NO. 7 | D&C RED NO. 7 | ECW0LZ41X8 | TABLET / SUBLINGUAL | 0.01 mg | ||
| GELATIN | GELATIN | 2G86QN327L | PASTE / DENTAL | 252 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LOTION / TOPICAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, CHEWABLE / ORAL | 24 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE / ORAL | 7 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PASTE, DENTIFRICE / DENTAL | 1.4 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED / ORAL | 0.03 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| D&C RED NO. 7 | D&C RED NO. 7 | ECW0LZ41X8 | TABLET / ORAL | 0.5 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, EXTENDED RELEASE / ORAL | 4.59 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, LIQUID FILLED / ORAL | 1.51 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CREAM / VAGINAL | 12 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / BUCCAL | 0.01 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, COATED / ORAL | 123 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, FILM COATED / ORAL | 1 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE / ORAL | 600 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET / SUBLINGUAL | 1.1 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER / ORAL | 48 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | GRANULE / ORAL | 12 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, DELAYED RELEASE / ORAL | 1.9 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET, FOR SUSPENSION / ORAL | 406 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SOLUTION / INTRAVENOUS | 34.8 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| D&C RED NO. 7 | D&C RED NO. 7 | ECW0LZ41X8 | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FILM COATED / ORAL | 240 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SUSPENSION / ORAL | 6 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SUSPENSION, EXTENDED RELEASE / ORAL | 1 mg | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / NASAL | 50 mg/1ml | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, COATED / ORAL | 2.5 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SUPPOSITORY / VAGINAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SUPPOSITORY / RECTAL | 0.11 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, DELAYED RELEASE / ORAL | 1791 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | TABLET / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SOLUTION / ORAL | 34.8 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 1 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | AEROSOL / TOPICAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | POWDER / RESPIRATORY (INHALATION) | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / ORAL | 75.3 mg/15ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SUSPENSION / ORAL | 20 mg/5ml |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4f445831-63ec-4b5f-9135-a3074f518fcc | c672cb8e-05a2-4ff5-b3bb-47acd955c2d9 | 2014-02-20 | Warnings, Adverse reactions | 4f445831-63ec-4b5f-9135-a3074f518fcc c672cb8e-05a2-4ff5-b3bb-47acd955c2d9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.