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Generic nameSTRONG IODINE SOLUTION
Labeler / manufacturerSafecor Health, LLC
RouteORAL
Drug classDrug class not supplied in source label
Product NDC48433-230
Label effective date2025-01-08
Official product label reference
Strong Iodine Solution — Safecor Health, LLC
This page contains 10 source sections for STRONG IODINE SOLUTION, oral route. Label set ec12b0ab-8fee-4b4f-a6e7-349f60a6f3e0, version 3.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
INDICATIONS Strong Iodine Solution, containing 5 percent of iodine and 10 percent of potassium iodide, is employed in the prophylaxis of simple and colloid goiters and in the treatment of exophthalmic goiter. It can be used alone as a preoperative preparation but is now most commonly used concomitantly with propylthiouracil and other antithyroid drugs. When used with these drugs, Strong Iodine Solution produces involution of the hyperplastic gland thus making a less triable and vascular gland for thyroidectomy. In addition, it has an additive antithyroid action that helps make the patient enthyroid faster than if the antithyroid drugs were used alone.
Dosage and administration — label text
DOSAGE Strong Iodine Solution is for oral use only. The usual dosage of Strong Iodine Solution is 2 to 6 drops (0.1 to 0.3 ml) three times daily taken in water after meals for two or three weeks prior to operation. In thyroid crisis the dosage is 1 ml three times a day.
Contraindications
CONTRAINDICATIONS The use of iodides may be contraindicated in patients with tuberculosis because it is believed they may cause a breakdown of healing lesions. The use of iodides is contraindicated in patients with iododerma, laryngeal edema, and swelling of salivary glands or increased salivation upon previous exposure to iodides. Strong Iodine Solution is ineffective in the treatment of postoperative thyroid crisis.
Warnings
WARNINGS Prolonged therapy may cause iodism. USE IN PREGNANCY: The drug readily crosses the placental barrier and may affect the fetus if used during pregnancy.
Adverse reactions
ADVERSE REACTIONS Ingestion of large quantities of Strong Iodine Solution may cause abdominal pain, nausea, vomiting and diarrhea. Average doses may cause skin rash.
Unclassified section
FOR ORAL USE ONLY
R x only SAFECOR HEALTH, LLC WOBURN, MA 01801 230-02 Rev 05/2019
Product description
DESCRIPTION Iodine 5g, potassium iodide 10g, in enough purified water to make 100 ml.
Precautions
PRECAUTIONS Iodine therapy does not completely control the manifestations of hyperthyroidism and after a variable period of time, the beneficial effects wear off. With continued administration of the drug, the hyperthyroidism may return in its initial intensity or become even more severe than it was at first. Measurements of the protein-bound iodine or of the uptake of radioiodine are rendered useless if iodine is given.
Supply and packaging
HOW SUPPLIED Bottles of 14 ml, amber glass with lined plastic closures. Accompanying each bottle is a glass dropper which should be used when the solution is ready to be dispensed to minimize any loss of free iodine through the bulb of the dropper.
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.