May be mixed with water or fruit juice and drink through a straw to avoid temporary staining of teeth. Do not mix with milk or wine based vehicles. As directed by a doctor or as follows Prevention of iron deficiency Adults: 5mL (1 unit dose) daily Children under 12 years of age: Consult of doctor Iron replacement therapy in deficiency states Adults: 5mL (1 unit dose) two (2) to four (4) times daily preferable betw...
| Serving Size: 5mL (1 Unit Dose) | ||
| Amount per serving | % Daily Value* | |
| Calories | 4 | |
| Total Carbohydrate | 1g | <1% |
| Sugars | 1g | ** |
| Includes 1g Added Sugars | 4% | |
| Iron (elemental) (as ferrous sulfate) | 60mg | 333% |
| *Percent Daily Value based on a 2,000 calorie diet **Daily Value not established |
Other ingredients: Purified water, sucrose, citric acid, sodium benzoate, and cinnamon flavor.
Use: Ferrous Sulfate Oral Solution is an iron supplement for the treatment and prevention of iron deficiency and iron deficient anemia when the need for such therapy has been determined by a healthcare professional.†
May be mixed with water or fruit juice and drink through a straw to avoid temporary staining of teeth. Do not mix with milk or wine based vehicles.
As directed by a doctor or as follows
Do not use
Oral Iron Supplements
Warnings
Do not exceed recommended dosage: The treatment of anemic conditions should be under the advice and supervision of a doctor. Occasional gastrointestinal or discomfort (such as nausea) may be minimized by taking supplement between meals. Also in order to minimize gastrointestinal or discomfort, may begin by taking 5 mL (1 unit dose) and increase dosage over time. Staining of teeth may occur with ferrous sulfate oral solution.
Warning: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under six (6). Keep out of reach of children. In case of accidental overdose call a doctor or contact a Poison Control Center right away. (1-880-222-1222) |
If pregnant or breast-feeding, ask a doctor before use.
Storage
• store at 20° to 25°C (68°to 77°F). [See USP Controlled Room Temperature]
• preserve in tight, light-resistant containers
• protect from freezing and light
• do not use if lid is torn or broken
Questions or comments? Call-1-844-474-7464
†This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
FG-27/Iss.:03/2023
Case label -57237-311-51 (100 x 5 mL Unit-Dose Cups)
Lid Label -57237-311-05 (Delivers 5 mL)
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57237-311-05 | FERROUS SULFATE | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | 1 | |
| 57237-311-51 | FERROUS SULFATE | 100 in 1 BOX, UNIT-DOSE | SOLUTION | 100 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-311-05 | ML - Milliliter | 57237-311 | 5ce1a03d-332e-4e17-b50c-3cea81c92216 | 1 | 2025-06-13 |
| 57237-311-51 | ML - Milliliter | 57237-311 | 60696054-f728-4b70-88df-adb7d48b036d | 1 | 2025-06-13 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 57237-311 | 57237-311-05, 57237-311-51 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FERROUS SULFATE | 39R4TAN1VT | ACTIM |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCROSE | C151H8M554 | IACT |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| FERRUM SULPHURICUM | FERROUS SULFATE | Boiron | 3a749d62-0e20-0c15-e063-6394a90ac1a8 | 2025-07-21 | FERROUS SULFATE | |
| FERROUS SULFATE | FERROUS SULFATE | Richmond Pharmaceuticals, Inc. | 58dd4f30-980b-44bc-9f8e-8d4626854b91 | 2024-12-26 | Warnings | FERROUS SULFATE FERROUS SULFATE |
| Ferrous Sulfate | FERROUS SULFATE | Richmond Pharmaceuticals Inc. | 5514d582-19b5-4f1e-b794-f790afb8211c | 2024-12-26 | Boxed warning, Warnings | Ferrous Sulfate FERROUS SULFATE |
| Ferrum sulphuricum | FERROUS SULFATE | Boiron | 7a4087d8-d054-bbdc-e053-2991aa0ae8cf | 2023-11-13 | FERROUS SULFATE |
Adverse event summaries are temporarily unavailable. Other product information remains available.