Dosage and administration
Do not crush or chew tablets. Adult Serving Size: 1 tablet two to three times daily. Children: Consult a physician.
Do not crush or chew tablets. Adult Serving Size: 1 tablet two to three times daily. Children: Consult a physician.
Dietary Supplement
Each tablet contains 324 mg of ferrous sulfate, equivalent to 65 mg of elemental iron, providing 362% of the U.S. recommended daily intake (RDI) of iron for adults and children 4 and older.
Do not crush or chew tablets. Adult Serving Size: 1 tablet two to three times daily. Children: Consult a physician.
| 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. |
Do not take within 2 hours of taking oral tetracycline antibiotics, since oral iron products tend to interfere with absorption of tetracycline. May cause gastrointestinal discomfort, nausea, constipation or diarrhea. If you are pregnant or nursing a baby, seek advice of a health professional before using this product. U.S. Consumer Product Safety Commission requires that iron-containing medicines and vitamins with iron be packaged in child-resistant closures. Parents should always properly resecure safety closures.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]
| Serving Size 1 Tablet | ||
|---|---|---|
| Amount Per Tablet | % Daily Value | |
| Iron (as ferrous sulfate) | 65 mg | 362% |
Other ingredients: Corn Starch, Calcium Stearate, Powdered Cellulose, Lactose, Talc, Copovidone, Polyethylene Glycol, Maltodextrin, Sucrose, Povidone, Calcium Carbonate, Titanium Dioxide, Magnesium Stearate, Shellac, Cocoa Butter, FD&C Red No. 40 Aluminum Lake, Sodium Starch Glycolate A, Sodium Lauryl Sulfate, Colloidal Silicon Dioxide, Methacrylic Acid Copolymer Type C, Sodium Hydroxide, Simethicone Emulsion, Diethyl Phthalate, Hypromellose, Carnauba Wax, White Wax.
Packaged by: Paddock Laboratories, Inc.
Minneapolis, MN 55427
(01-08)
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
NDC 54868-6324-0
FERROUS SULFATE
ENTERIC-COATED TABLETS
324 mg
Dietary
Supplement
CONTAINS: Each tablet contains 324 mg
of ferrous sulfate, equivalent to 65 mg of
elemental iron, providing 362% of the U.S.
recommended daily intake (RDI) of iron for
adults and children 4 and older.
DIRECTIONS FOR USE: Do not crush or chew
tablets. Adult Serving Size: 1 tablet two to three
times daily. Children: Consult a physician.
NET CONTENTS 100 TABLETS
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1860100 | ferrous sulfate 324 MG (iron 65 MG) Delayed Release Oral Tablet | PSN | 2 |
| 1860100 | ferrous sulfate 324 MG Delayed Release Oral Tablet | SCD | 2 |
| 1860100 | ferrous sulfate 324 MG (iron 65 MG) Delayed Release Oral Tablet | SY | 2 |
| 1860100 | FESO4 324 MG Delayed Release Oral Tablet | SY | 2 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54868-6324-0 | Ferrous Sulfate | 100 in 1 BOTTLE | TABLET | 100 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54868-6324 | FERROUS SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | 1 package rows | 20121106_fa8c6222-9641-429c-a4e2-9d2743bfdb61.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54868-6324-0 | EA - Each | 54868-6324 | fdf66871-8b70-4e1d-83eb-74acf6fe0397 | 1 | 2013-02-19 |
| 0574-0608-01 | EA - Each | 0574-0608 | 9f1a99dd-2e05-454f-be2a-4a3d63ae9c5c | 1 | 2013-02-19 |
| 0574-0608-10 | EA - Each | 0574-0608 | bb3df45b-bbb5-460c-97d8-05f61afedc08 | 1 | 2013-02-19 |
| 0574-0608-11 | EA - Each | 0574-0608 | 41125e63-93e1-46b1-a8ae-8e42b8e61d0d | 1 | 2013-02-19 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| FERROUS SULFATE | ACTIVE INGREDIENT | 39R4TAN1VT | 2 | |
| FERROUS CATION | ACTIVE MOIETY | GW89581OWR | 2 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | 2 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 2 | |
| COCOA BUTTER | INACTIVE INGREDIENT | 512OYT1CRR | 2 | |
| COPOVIDONE K25-31 | INACTIVE INGREDIENT | D9C330MD8B | 2 | |
| DIETHYL PHTHALATE | INACTIVE INGREDIENT | UF064M00AF | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 2 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | 2 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 2 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | 2 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54868-6324 | 54868-6324-0 |
| 0574-0608 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRATHECAL | ADJ PH | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, DELAYED RELEASE / ORAL | 79 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / EPIDURAL | ADJ PH | ||
| DIETHYL PHTHALATE | DIETHYL PHTHALATE | UF064M00AF | CAPSULE, COATED PELLETS / ORAL | 6.8 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | CAPSULE, COATED PELLETS / ORAL | 29 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED PELLETS / ORAL | 14 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET, COATED / ORAL | 40.2 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / TOPICAL | 0.2 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET / SUBLINGUAL | 1.1 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | TABLET, COATED / ORAL | 30 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, DELAYED RELEASE / ORAL | 46 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET, DELAYED RELEASE / ORAL | 16 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | POWDER / RESPIRATORY (INHALATION) | 90 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, COATED / ORAL | 64.8 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAVESICAL | ADJ PH | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | LOTION / TOPICAL | 111 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRACAUDAL | ADJ PH | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 60 mg | ||
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | NX76LV5T8J | CAPSULE, COATED / ORAL | 56 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET / ORAL | 320 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CONCENTRATE / ORAL | 10 mg/5ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAMUSCULAR | 78 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | NX76LV5T8J | TABLET, EXTENDED RELEASE / ORAL | 403 mg | ||
| COPOVIDONE K25-31 | COPOVIDONE K25-31 | D9C330MD8B | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / ORAL | 2500 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | GUM, CHEWING / BUCCAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LOTION, AUGMENTED / TOPICAL | ADJ PH | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | SOLUTION / ORAL | 1451 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | POWDER, DENTIFRICE / DENTAL | 0.5 mg/mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | IMPLANT / SUBCUTANEOUS | 6 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / TOPICAL | ADJ PH | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | SUSPENSION / ORAL | 3 mg/1ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| DIETHYL PHTHALATE | DIETHYL PHTHALATE | UF064M00AF | TABLET, DELAYED RELEASE / ORAL | 131 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | SUSPENSION / ORAL | 6040 mg | ||
| COPOVIDONE K25-31 | COPOVIDONE K25-31 | D9C330MD8B | TABLET / SUBLINGUAL | 54 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CAPSULE / ORAL | 79 mg |
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.