As directed by a doctor or as follows: Prevention of iron deficiency Adults: 5 mL (1 teaspoonful) daily Children under 12 years of age: consult a doctor Iron replacement therapy in deficiency states Adults: 5 mL (1 teaspoonful) 2 to 4 times daily preferably between meals. Children under 12 years of age: consult a doctor Mix with water or fruit juice and drink through a straw to avoid temporary/staining of te...
| Serving Size: 1 teaspoonful (5 mL) |
| Amount Per Serving % DV* |
| Iron (elemental) 60 mg 33% |
| *Percent Daily Values (DV) are based on a 2,000 calorie diet. |
Ferrous Sulfate USP 300 mg (60 mg elemental iron) per 5 mL, citric acid, flavoring, purified water, sodium benzoate, sodium citrate, and sucrose.
Ferrous Sulfate Oral Solution USP is an iron supplement for the prevention and treatment of iron deficiency and iron deficiency anemia when the need for such therapy has been determined by a doctor.
As directed by a doctor or as follows:
Prevention of iron deficiency
Adults: 5 mL (1 teaspoonful) daily
Children under 12 years of age: consult a doctor
Iron replacement therapy in deficiency states
Adults: 5 mL (1 teaspoonful) 2 to 4 times daily preferably between meals.
Children under 12 years of age: consult a doctor
Mix 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,
Do not use:
Consult a doctor before use if you are pregnant or nursing.
Oral iron supplements:
Consult a doctor before use if you are pregnant or nursing.
Oral iron supplements:
Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a doctor. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals and by beginning with one teaspoonful the first day, two the second, etc., until the recommended dosage is reached. Ferrous Sulfate Oral Solution may cause temporary staining of the teeth. This is less likely when the product is diluted. Accidental overdose of iron-containing products is a leading cause of
fatal poisoning in children under 6.
In case of accidental overdose, call a doctor or poison control center immediately.
Yellow colored, cinnamon flavored oral solution supplied in the following oral dosage form:
Product Code 63739-157-70: 5 mL Unit Dose Cup
Product Code 63739-157-10: Case of 100, 5 mL Unit Dose Cups
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]
Protect from freezing. Protect from light.
Questions or comments? Call 1-800-845-8210. You may also report serious side effects to this phone number. Call your doctor for medical advice about side effects.
Distrbuted By:
McKesson Corporation
dba SKY Packaging
Memphis, TN 38141
Iss. 03/2022
63739-157-70
Delivers 5 mL
Ferrous Sulfate Oral Solution USP
300 mg/5 mL
(Equivalent to approximately 60 mg elemental iron)
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63739-157-10 | ML - Milliliter | 63739-157 | f3c7e95d-15bf-4212-a103-ef5035171ea3 | 1 | 2024-09-09 |
| 63739-157-70 | ML - Milliliter | 63739-157 | da327cdd-211a-484a-9d7e-03c2b2f4b95c | 1 | 2024-09-09 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63739-157 | 63739-157-70, 63739-157-10 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FERROUS SULFATE FE-59 | 5YW2843AG6 | ACTIB |
| CITRIC ACID ACETATE | DSO12WL7AU | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCROSE | C151H8M554 | 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 |
|---|---|---|---|---|---|---|
| 2380c8ab-bbcb-2a8f-e063-6394a90a0dba | 8710fd7d-6ec3-45f3-b124-e10250e76c82 | 2024-10-02 | Warnings | 8710fd7d-6ec3-45f3-b124-e10250e76c82 |
Adverse event summaries are temporarily unavailable. Other product information remains available.