Active Ingredients
Supplemental Facts
Serving Size 1 Tablet Servings per Container 100
Amount Per Tablet % Daily Value
Iron (as Ferrous Sulfate) 65 mg 361%
Calcium 20 mg 2%
Ferrous Sulfate
FDA Label NDC 58607-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Martin Ekwealor Pharmaceuticals, Inc. for the product Ferrous Sulfate (NDC 58607-113). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, keep out of reach of children., indications and usage, warnings: precautions:, directions:, other ingredients:, storage:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
NATURAL IRON SUPPLEMENT
Keep Out Of Reach Of Children.
WARNING: Accidental overdose of iron-containing products is a leading cause of poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Indications And Usage
NATURAL IRON SUPPLEMENT. The treatment of any anemic condition should be under the advise and supervision of a doctor.
Warnings: Precautions:
WARNING: Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a doctor. Occasional gastrointestinal discomfort like nausea may be minimized with meals. Iron-containing drugs may cause constipation or diarrhea.
PRECAUTIONS: Since oral iron products interfere with absorption of tetracycline antibiotics, these products should not be taken within two hours of each other.
Directions:
Adults only. One tablet daily, preferably with a meal or as directed by a physician.
Other Ingredients:
Dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, FD and C red #40 (AL Lake), FD and C blue #2/Indigo Carmine (Al Lake), macrogol, PEG 400, silicon dioxide, titanium dioxide, talc, vanillin.
Storage:
Store between 15° - 30° C (59° -86° F)
Ferrous Sulfate Product Label
58607-113-10
NATURAL IRON SUPPLEMENT
FERROUS SULFATE
5 gr (325 mg)
100 Tablets
MADE WITH PRIDE IN THE U.S.A.
M.E. Pharmaceuticals, Inc.
Richmond, IN 47374
Lot No:
Exp Date:
Mepharm Ferroussulfate Label (Mepharm Ferroussulfate)
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