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
- 2016-03-22
- Label type
- Human OTC Drug Label
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:45:40
Label at a glance#
ProductFerrous Sulfate
Active ingredientFERROUS SULFATE
Label structure11 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)
PRINCIPAL DISPLAY PANEL - 325 MG Tablet Bottle Label
CommUnityCare Federally Qualified Health Centers
FERROUS
SULFATE
325MG #
100
Date:
Name:
Dr.
TAKE 1 TABLET 1 TO 3 TIMES PER DAY WITH FOOD, AS
DIRECTED.
123456
1/1/01
FERROUS SULF 325MG TABS# 100 NDC 76413-308-01
Batch: 123456
Lot: 123456
Exp: 1/1/01
SUN PHARMA
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 310325 | ferrous sulfate 325 MG (iron 65 MG) Oral Tablet | PSN | 1 |
| 310325 | ferrous sulfate 325 MG Oral Tablet | SCD | 1 |
| 310325 | ferrous sulfate 324 MG (iron 65 MG) Oral Tablet | SY | 1 |
| 310325 | ferrous sulfate 325 MG (iron 65 MG) Oral Tablet | SY | 1 |
| 310325 | FESO4 325 MG Oral Tablet | SY | 1 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76413-308-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2703-f424-e053-dadaa90a57ce | Ferrous Sulfate Film Coated Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76413-308-01 | Ferrous Sulfate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57664-071-01 | EA - Each | 57664-071 | 6ebb4586-ec2f-4e6f-9698-a8bcf4b5cdf8 | 1 | 2015-01-05 |
| 57664-071-10 | EA - Each | 57664-071 | 3c82e928-f3ca-4389-998d-1e65681d9782 | 1 | 2015-01-05 |
Products#
Every source-derived product name is available through these pages.
- Ferrous Sulfate
- FERROUS CATION
- CELLULOSE, MICROCRYSTALLINE
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- CROSCARMELLOSE SODIUM
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- HYPROMELLOSES
- STEARIC ACID
- POLYETHYLENE GLYCOL 400
- FD&C RED NO. 40
- MAGNESIUM STEARATE
- TITANIUM DIOXIDE
- POLYETHYLENE GLYCOL 8000
- CARNAUBA WAX
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76413-308 | 76413-308-01 |
| 57664-071 |
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 |
|---|---|---|---|---|---|---|
| 909b743b-50a1-4bb6-afbf-87a8b12157d1 | c57a8573-d5ae-48b2-afb7-bbec2f63afff | 2016-03-22 | Warnings | 909b743b-50a1-4bb6-afbf-87a8b12157d1 c57a8573-d5ae-48b2-afb7-bbec2f63afff |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.