Ferrous sulfate

Ferrous sulfate is used for iron replacement in confirmed iron deficiency, with or without iron-deficiency anemia. Assess the cause and ongoing loss rather than treating fatigue or a low hemoglobin value alone.

The selected U.S. package has Supplement Facts and is marketed as an iron supplement. DailyMed metadata calls it a human OTC product in the category unapproved drug other; neither an NDC nor DailyMed inclusion establishes FDA approval. FDA does not preapprove dietary supplements for safety/effectiveness. Clinical guideline use should not be recast as an FDA-approved supplement indication.

This profile covers oral ferrous sulfate and selected pediatric guideline examples. IV iron products, other iron salts and iron-containing combinations have separate doses/risks; they are not interchangeable milligram-for-milligram.

One selected tablet contains 325 mg ferrous sulfate, equivalent to 65 mg elemental iron. The package suggests one tablet daily for adults, preferably after meals or as directed by the doctor; children require doctor-directed dosing. This package instruction is not a universal treatment regimen.

The BSG adult guideline suggests initial oral replacement of approximately 50–100 mg elemental iron once daily. A clinician may reduce frequency to every other day if poorly tolerated, or consider another preparation/IV iron if oral therapy is unsuitable. Treatment frequency and food timing should follow the chosen care plan.

RCH guidance for infants/children older than 1 month uses elemental doses: prevention 1–2 mg/kg/day, maximum 30 mg/day; treatment 3–6 mg/kg/day. Severe anemia warrants specialist assessment and higher-end dosing. Neonates need local neonatal guidance. These are clinical regimens, not permission to give an adult supplement tablet to a child.

RCH lists Ferro-liquid at 6 mg elemental iron/mL and a 325 mg Ferro-grad modified-release tablet at 105 mg elemental iron. Thus “325 mg ferrous sulfate” alone cannot identify elemental delivery across salt hydration/forms and markets. Use the package’s elemental amount; do not substitute the selected U.S. 65 mg conversion universally.

NIH lists healthy-population total-intake ULs of 40 mg/day through age 13 and 45 mg/day from age 14. Clinician-supervised deficiency treatment may exceed these; the UL is not a treatment ceiling. Do not add prenatal/multivitamin or other iron to a prescribed regimen without counting it.

The selected supplement-style label has no formal prescription contraindications section. Known product/excipient allergy and established iron overload require avoidance or specialist assessment; anemia from another cause does not justify iron automatically. Do not invent a universal FDA contraindication list or substitute supplement warnings for a full disease assessment.

The reviewed package carries a prominent child-poisoning warning. It is not a prescription-drug FDA boxed warning. That distinction does not diminish the potentially fatal overdose risk.

The selected label reports occasional nausea/GI discomfort and constipation or diarrhea. Pediatric guidance also notes dark stools and tooth staining with liquids. Darkening alone can occur with oral iron; concerning bleeding symptoms or severe illness still needs assessment.

The selected label says oral tetracyclines and iron should not be taken within 2 hours of each other. Check the exact antibiotic’s current instructions; a generic iron instruction must not override a longer required separation.

Separate levothyroxine tablets and iron by at least 4 hours per relevant thyroid-product instructions; concomitant iron can reduce thyroid-drug efficacy. Iron may also reduce levodopa absorption/effect; coordinate administration and monitor clinical response.

PPIs can impair iron absorption in deficient patients; review a poor response. Calcium supplements may interfere, so take individual iron and calcium supplements at different times. Meals can improve tolerability for the selected package, while fasting administration improves absorption in adult treatment guidance; choose an explicit plan rather than issuing both instructions without context.

Count all iron-containing supplements and combinations. RCH advises against concurrent oral/parenteral iron and recommends withholding oral iron for at least a week after an infusion; IV-product/local specialist instructions govern the actual restart.

The selected package directs pregnant/nursing patients to seek professional advice. NIH adult dietary RDAs are 27 mg/day in pregnancy and 9 mg/day during lactation (10 mg for lactating adolescents). These are total-intake targets, not treatment doses; include prenatal iron when assessing exposure.

Use a measured, verified elemental-iron liquid when prescribed; pediatric regimens and formulation choices require supervision. RCH’s dose guidance applies after 1 month, with neonatal dosing referred separately. An adult tablet’s supplement direction does not establish pediatric approval or a weight-based conversion.

The selected label provides no validated creatinine-clearance or hepatic adjustment table. CKD/inflammation can produce functional iron restriction and poor oral response; older-adult anemia is often multifactorial. Assess iron status and the underlying disease with the appropriate specialist plan instead of assigning an unsupported fixed dose reduction. Iron-overload liver disease requires particular caution.

Iron supports hemoglobin/myoglobin and normal oxygen handling. Ferrous salts provide absorbable iron, but uptake varies with stores, formulation and diet; a fixed oral dose is not completely absorbed.

Hepcidin limits gut iron absorption and helps explain poor oral response in inflammatory functional deficiency. Modified-release preparations may release iron beyond more active absorption sites; the BSG adult guideline does not recommend them as a strategy to improve absorption or reduce adverse effects.

The selected package provides no product-specific concentration-time, elimination half-life or bioequivalence study. This profile does not invent an oral iron half-life or use a single serum-iron value as proof of repleted stores.

Assess CBC and iron stores with clinical context; ferritin can be misleading with inflammation. The BSG guideline advises checking hemoglobin response within 4 weeks and continuing around 3 months after normalization, adjusted to repletion/ongoing loss. Investigate nonresponse rather than automatically escalating.

RCH recommends early review within a week for severe anemia and continuing at least 3 months after correction, with hemoglobin/ferritin reassessment. Check adherence and concentration errors; persistent deficiency needs pediatric review.

Follow the agreed food/frequency plan, use the correct measuring device for prescribed liquids and protect teeth as advised. Report intolerable GI effects. If oral treatment is ineffective, intolerable or unsuitable, a clinician can consider IV replacement; this profile provides no IV conversion or emergency anemia/transfusion protocol.

The retained selected label contains inconsistent older “U.S. RDA” percentage text alongside Supplement Facts. The verified amount is 65 mg elemental iron; this profile deliberately does not publish either percentage as a dose or clinical target. Check the current dispensed carton.

Selected Richmond Pharmaceuticals red oral tablets: 325 mg ferrous sulfate, 65 mg elemental iron per tablet; 100 tablets in unit-dose packaging, NDC 54738-963-13. The label compares its ingredient to Feosol but explicitly disclaims affiliation; it is not the branded Feosol package.

Reviewed U.S. tablet and RCH liquid/modified-release examples are listed in the dose table. The selected carton uses Supplement Facts while its DailyMed metadata uses an unapproved OTC category. No FDA-approved universal liquid concentration, release-form equivalence or iron-salt interchangeability is asserted.

The selected tablet label specifies a dry place at 15–30°C, avoiding excess heat/moisture. Do not use damaged/tampered blister units. Keep the carton for information and store every iron product securely away from children; liquids and other brands require their own storage directions.