Boxed 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.
Ferrous Sulfate
- Manufacturer
- Healthlife of USA | Advance Pharmaceuticals
- Effective date
- 2017-12-05
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:06:07
Label at a glance#
ProductFerrous Sulfate
Active ingredientFERROUS SULFATE
Label structure7 sections
Dosage and administration
Adults and children 12 years of age and over: Take one tablet daily, preferably after a meal, or as directed by a physician. Children under 12 years of age: consult a physician. Do not chew or crush tablet. Tablets are enteric-coated to help protect your stomach.
Contacts and useful links#
Label contents#
Full prescribing information#
Amount per serving
Iron (as dried ferrous sulfate) 65mg.............360%
Directions
Adults and children 12 years of age and over: Take one tablet daily, preferably after a meal, or as directed by a physician. Children under 12 years of age: consult a physician. Do not chew or crush tablet. Tablets are enteric-coated to help protect your stomach.
Other Ingredients
Dicalcium phosphate, microcrystalline cellulose, stearic acid, croscarmellose sodium, magnesium stearate, silica, methacrylic acid copolymer, propylene glycol, talc, titanium dioxide, polysorbate, sodium lauryl sulfate, polyvinyl alcohol, FD&C Red #40.
Warnings
Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other. Iron-containing products may cause constipation or diarrhea. As with any dietary supplement, if you are pregnant or nursing a baby, seek advice of a health professional before using this product.
Boxed 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.
Storage
Store in a cool, dry place.
Protect contents from light and moisture. you may report side effects by calling 1-844-221-7294.
Ferrous Sulfate Iron supplement therapy325mg each tablet30 Tablets
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69517-133-30 | 2024-06-13 | C162847 | 48780-1 | d6a99b39-4e8d-a426-e053-dadaa90af4c2 | Ferrous Sulfate Iron supplement therapy |
| 69517-133-30 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-4e8d-a426-e053-dadaa90af4c2 | Ferrous Sulfate Iron supplement therapy |
Products#
Every source-derived product name is available through these pages.
- Ferrous Sulfate
- Iron Supplement Therapy
- FERROUS CATION
- CALCIUM PHOSPHATE
- MICROCRYSTALLINE CELLULOSE
- STEARIC ACID
- CROSCARMELLOSE SODIUM
- MAGNESIUM STEARATE
- METHACRYLIC ACID
- PROPYLENE GLYCOL
- TALC
- TITANIUM DIOXIDE
- SODIUM LAURYL SULFATE
- POLYVINYL ALCOHOL, UNSPECIFIED
- FD&C RED NO. 40
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69517-133 | 69517-133-30 |
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 |
|---|---|---|---|---|---|---|
| 085ae7cd-f17d-e74a-e063-6394a90a9f9e | 38104333-f334-4d97-8657-94a00942faf2 | 2024-06-13 | Boxed warning, Warnings | 38104333-f334-4d97-8657-94a00942faf2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.