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
- Sun Pharmaceutical Industries, Inc.
- Effective date
- 2014-12-11
- Label type
- Human OTC Drug Label
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:34:20
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)
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
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 |
| 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 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| FERROUS SULFATE | ACTIVE INGREDIENT | 39R4TAN1VT | 1 | |
| FERROUS CATION | ACTIVE MOIETY | GW89581OWR | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 1 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | 1 | |
| RIBOFLAVIN | INACTIVE INGREDIENT | TLM2976OFR | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Ferrous Sulfate
- FERROUS CATION
- CELLULOSE, MICROCRYSTALLINE
- CALCIUM PHOSPHATE, DIBASIC, 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
- RIBOFLAVIN
- FD&C BLUE NO. 1
- FD&C BLUE NO. 2
- FD&C YELLOW NO. 6
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57664-071 | 57664-071-10, 57664-071-01 |
| 57664-070 | 57664-070-10, 57664-070-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | TABLET, FILM COATED / ORAL | 953 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CREAM / TOPICAL | 10 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1576 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, EXTENDED RELEASE / ORAL | 4.59 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | AEROSOL, POWDER / TOPICAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE / ORAL | 257 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE, FOR SUSPENSION / ORAL | 1.7 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION, SOLUTION / INTRAMUSCULAR | 20.3 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, EXTENDED RELEASE / ORAL | 2.78 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION / ORAL | 11 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE / ORAL | 45 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / TOPICAL | 6300 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | MOUTHWASH / BUCCAL | 0.01 mg/1ml | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CONCENTRATE / ORAL | 3000 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| POLYETHYLENE GLYCOL 8000 | POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | TABLET, DELAYED RELEASE / ORAL | 29 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, EXTENDED RELEASE / ORAL | 1472 mg | ||
| POLYETHYLENE GLYCOL 8000 | POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | TABLET, FILM COATED / ORAL | 49 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, EXTENDED RELEASE / ORAL | 2150 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | FILM, SOLUBLE / ORAL | 29 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOAP / TOPICAL | 0.2 %w/w | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | SOAP / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE / ORAL | 13440 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FOR SUSPENSION / ORAL | 1875 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, DELAYED RELEASE / ORAL | 230 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| POLYETHYLENE GLYCOL 8000 | POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | FILM / SUBLINGUAL | 24 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | OINTMENT / TOPICAL | 1950 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION / INTRAVENOUS | 28216 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION / TOPICAL | 11100 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg |
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 |
|---|---|---|---|---|---|---|
| bca6e06f-e9ea-4957-af87-453044fbf10b | bca6e06f-e9ea-4957-af87-453044fbf10b | 2014-12-11 | Warnings | bca6e06f-e9ea-4957-af87-453044fbf10b bca6e06f-e9ea-4957-af87-453044fbf10b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.