Active Ingredient (In Each 5 Ml) (One Teaspoonful)
Ferrous Sulfate 220 mg (44 mg of elemental Iron)
Ferrous Sulfate
FDA Label NDC 53807-177
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rij Pharmaceutical Corporation for the product Ferrous Sulfate (NDC 53807-177). 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 ingredient (in each 5 ml) (one teaspoonful), purpose, uses, adverse reactions:, do not use, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Iron Supplement
Uses
a therapy for simple iron deficiency and iron deficiency anemia
Adverse Reactions:
occasional gastrointestinal discomfort such as nausea dose related bowel effects (such as constipation or diarrhea), gastrointestinal effects may be minimized by the administration with or immediately after meals and bowel effects reduced by giving the minimum effective dosage.
Do Not Use
- more than directed
The treatment of any anemic condition should be under the advice and supervision of a physician
Ask A Doctor Or Pharmacist Before Use If You Are
taking oral Tetracycline antibiotics. Oral iron products interfere with absorption of oral tetracycline antibiotics. These products should not be taken within two hours of each other.
When Using This Product
- may occasionally cause constipation or diarrhea
- may cause temporary staining of the teeth (this is less likely when diluted)
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep This And All Drugs Out Of Reach Of Children.
Contains iron, which can be harmful or fatal to children in large doses. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.
Treatment Of Overdose:
quickly induce vomiting, then feed eggs and milk until gastric lavage can be done. Lavage with 1 percent Sodium Bicarbonate and administer an iron chelating agent (such as deferoxamine mesylate) BAL should not be used. Gastric lavage should not be performed after the first hour because the danger of perforation due to gastric necrosis. Measures to combat shock, dehydration, blood loss and respiratory failure may be necessary.
Directions
Mix with water or fruit juice to avoid temporary staining of the teeth, do not mix with milk or wine-based vehicles
| Adults and children 12 years of age and over | 1 teaspoonful daily, or as directed by a physician |
| Children under 12 years of age | Consult a physician |
Inactive Ingredients
citric acid, FD & C yellow #6, flavor, sodium benzoate, sucrose and water.
Other Information
- Store in tight, light-resistant container at room temperature
* Please review the disclaimer below.
