Dosage and administration
One tablet daily or as directed by a physician. For children under 12, consult a physical before using this product. Do not exceed recommended dosage. Do not use except under the advice and supervision of a physician.
Ferrous Sulfate Film Coated Tablets
- Manufacturer
- Central Texas Community Health Centers
- Effective date
- 2019-01-03
- Label type
- Human OTC Drug Label
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:58:04
Label at a glance#
ProductFerrous Sulfate
Active ingredientFERROUS SULFATE
Label structure12 sections
Storage and handling
Store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)
Contacts and useful links#
Label contents#
Full prescribing information#
ACTIVE INGREDIENT(S)
EACH TABLET CONTAINS:
| Dried Ferrous Sulfate, equivalent to 325 mg Ferrous Sulfate per tablet. | |
| Amount per tablet | % Daily Value |
| Iron 65 mg | 361% |
INACTIVE INGREDIENTS
Other ingredients for Red Tablets: microcrystalline cellulose, dibasic calcium phosphate dihydrate, croscarmellose sodium, sodium starch glycolate, hypromellose, stearic acid, polyethylene glycol (PEG) 400, FD&C red #40 aluminum lake, magnesium stearate, titanium dioxide, polyethylene glycol (PEG) 8000, carnauba wax
Other ingredients for Green Tablets: microcrystalline cellulose, dibasic calcium phosphate dihydrate, croscarmellose sodium, sodium starch glycolate, hypromellose, stearic acid, polyethylene glycol (PEG) 400, magnesium stearate, riboflavin, FD&C bule #1 aluminum lake, titanium dioxide, FD&C blue #2 aluminum lake, polyethylene glycol (PEG) 8000, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, carnauba wax
PURPOSE
Dietary Supplement
USE(S)
One tablet daily or as directed by a physician. For children under 12, consult a physician before using this product.
WARNINGS
Iron may interfere with absorpiton of certain antibiotics; these products should not be taken within two hours of each other.
Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking iron with meals. Iron-containing products may occassionally cause constipation or diarrhea. If pregnant or nursing consult a physicial before using this product.
DO NOT USE
TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING
OTHER REQUIRED WARNINGS
| The information on this label has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, trea, cure or prevent any disease. |
To report a serious adverse event or to obtain product information, contact 800-818-4555.
KEEP 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 reach of children. In case of accidental overdose, call a doctor or poison control center immediately. |
DIRECTIONS
One tablet daily or as directed by a physician. For children under 12, consult a physical before using this product.
Do not exceed recommended dosage.
Do not use except under the advice and supervision of a physician.
STORAGE
Store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)
HOW SUPPLIED
Product: 76413-356
NDC: 76413-356-01 100 TABLET, FILM COATED in a BOTTLE
FERROUS SULFATE TABLET, FILM COATED
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 310325 | ferrous sulfate 325 MG (iron 65 MG) Oral Tablet | PSN | 2 |
| 310325 | ferrous sulfate 325 MG Oral Tablet | SCD | 2 |
| 310325 | ferrous sulfate 324 MG (iron 65 MG) Oral Tablet | SY | 2 |
| 310325 | ferrous sulfate 325 MG (iron 65 MG) Oral Tablet | SY | 2 |
| 310325 | FESO4 325 MG Oral Tablet | SY | 2 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76413-356-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2e3b-a910-e053-dadaa90a0b85 | Ferrous Sulfate Film Coated Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76413-356-01 | Ferrous Sulfate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57664-070-01 | EA - Each | 57664-070 | f8f5b771-24d6-4924-93ef-1b14cbb0d895 | 1 | 2015-01-05 |
| 57664-070-10 | EA - Each | 57664-070 | 945c8086-99ad-448c-b3e1-02e5ec206a19 | 1 | 2015-01-05 |
Products#
Every source-derived product name is available through these pages.
- Ferrous Sulfate
- FERROUS CATION
- MICROCRYSTALLINE CELLULOSE
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- CROSCARMELLOSE SODIUM
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- HYPROMELLOSE, UNSPECIFIED
- STEARIC ACID
- POLYETHYLENE GLYCOL 400
- FD&C RED NO. 40
- MAGNESIUM STEARATE
- TITANIUM DIOXIDE
- POLYETHYLENE GLYCOL 8000
- CARNAUBA WAX
- RIBOFLAVIN
- FD&C BLUE NO. 1
- FD&C BLUE NO. 2
- FD&C YELLOW NO. 6
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76413-356 | 76413-356-01 |
| 57664-070 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| 759bc81c-e231-46eb-80e6-4b31466d94ed | 567e3c88-f9e8-4421-aba6-1983faa5f15a | 2019-01-03 | Warnings | 759bc81c-e231-46eb-80e6-4b31466d94ed 567e3c88-f9e8-4421-aba6-1983faa5f15a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.