OVERDOSAGE SECTION.

Overdosage. Acute toxicity from potassium iodide is relatively rare. An occasional individual may show marked sensitivity and the onset of acute poisoning can occur immediately or hours after administration. Angioedema, laryngeal edema and cutaneous hemorrhages may occur.Iodism or chronic iodine poisoning may occur during prolonged treatment or with the use of high doses. Symptoms of iodism typically disappear soon after discontinuation of the drug. Abundant fluid and salt intake aids in iodide elimination.

ADVERSE REACTIONS SECTION.

Adverse Reactions. The most frequent adverse reactions to potassium iodide are stomach upset, diarrhea, nausea, vomiting, stomach pain, skin rash, and salivary gland swelling or tenderness. Less frequent adverse reactions include gastrointestinal bleeding, confusion, irregular heartbeat, numbness, tingling, pain or weakness in hands or feet, unusual tiredness, weakness or heaviness of legs, fever, and swelling of neck or throat. Thyroid adenoma, goiter, and myxedema are possible side effects.Iodism or chronic iodine poisoning may occur during prolonged treatment or with the use of high doses. The symptoms of iodism include burning of mouth or throat, severe headache, metallic taste, soreness of teeth and gums, symptoms of head cold, irritation of the eyes with swelling of the eyelids, unusual increase in salivation, acneform skin lesions in the seborrheic areas, and rarely, severe skin eruptions. If symptoms of iodism appear, the drug should be withdrawn and the patient given appropriate supportive therapy.Hypersensitivity to iodides may occur and may be manifested by angioedema, cutaneous and mucosal hemorrhage, and signs and symptoms resembling serum sickness, such as fever, arthralgia, lymph node enlargement, and eosinophilia.

DOSAGE & ADMINISTRATION SECTION.

Dosage and Administration. Adults 0.3 mL (300 mg) or 0.6 mL (600 mg) diluted in one glassful of water, fruit juice or milk to times daily. To minimize gastric irritation, take with food or milk.This medication should be used no longer than necessary to produce the desired effect.

DRUG INTERACTIONS SECTION.

Drug Interactions. Concurrent use with lithium or antithyroid drugs may potentiate the hypothyroid and goitrogenic effects of these medications. Concurrent use with potassium-containing medications, potassium-sparing diuretics and angiotensin-converting enzyme inhibitors (ACE inhibitors) may result in hyperkalemia and cardiac arrhythmias or cardiac arrest.

GENERAL PRECAUTIONS SECTION.

General. In some patients, prolonged use of iodides can lead to hypothyroidism. Iodides should be used with caution in patients having Addisons disease, cardiac disease, hyperthyroidism, myotonia congenita, tuberculosis, acute bronchitis, or renal function impairment.

HOW SUPPLIED SECTION.

How Supplied. Potassium Iodide Oral Solution, USP is supplied in fluid ounce (30 mL) bottles (NDC 16477-601-01) with calibrated dropper marked to deliver 0.3 mL (300 mg) and 0.6 mL (600 mg); and fluid ounce (237 mL) bottles (NDC 16477-601-08). Inactive ingredient: Sodium thiosulfate as preservative.Store at 20 to 25C (68 to 77F); excursions permitted to 15 to 30C (59 to 86F) [See USP Controlled Room Temperature]. Keep tightly closed and protected from light.For the 237mL bottle, dispense in tight, light-resistant containers with child-resistant closures. For the 30mL bottle, place the child-resistant cap back on the amber glass bottle after using the clear plastic dropper for dispensing.Notice: When exposed to cold temperatures, crystallization may occur, but on warming and shaking, the crystals will redissolve. If the solution turns brownish-yellow in color, it should be discarded.

INDICATIONS & USAGE SECTION.

Indications and Usage. Potassium Iodide Oral Solution, USP is for use as an expectorant in the symptomatic treatment of chronic pulmonary diseases where tenacious mucus complicates the problem, including bronchial asthma, bronchitis and pulmonary emphysema.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Potassium Iodide Oral Solution, USP (saturated)1g/mL1 Fluid Oz. (30 mL)8 Fluid Oz. (237 mL)Rx onlyLASER Pharmaceuticals, LLCUSUAL DOSAGE: Adults 0.3 mL (300 mg) or 0.6 mL (600 mg) diluted in one glassful of water, fruit juice or milk to times daily. To minimize gastric irritation, take with food or milk. This medication should be used no longer than necessary to produced the desired affect.Store at 20 to 25C (68 to 77F), excursions permitted to 15 to 30C (59 to 86F) [See USP Controlled Room Temperature]. Keep tightly closed and protected from light. Dispense in tight, light-resistant containers with child-resitant closures. Notice: When exposed to cold temperatures, crystallization may occur, but on warming and shaking, the crystals will redissolve. If the solution turns brownish-yellow in color, it should be discarded.KEEP OUT OF REACH OF CHILDRENManufactured for Laser Pharmaceuticals, LLC, Alpharetta, GA 30004All prescription substitutions and/or recommendations using this produvt shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending prescription substitution using this product shall make such recommendations based on each persons professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical informaiton provided herein. Rev. 05-22 1 oz label. oz label.

PRECAUTIONS SECTION.

Precautions. General. In some patients, prolonged use of iodides can lead to hypothyroidism. Iodides should be used with caution in patients having Addisons disease, cardiac disease, hyperthyroidism, myotonia congenita, tuberculosis, acute bronchitis, or renal function impairment.. Drug Interactions. Concurrent use with lithium or antithyroid drugs may potentiate the hypothyroid and goitrogenic effects of these medications. Concurrent use with potassium-containing medications, potassium-sparing diuretics and angiotensin-converting enzyme inhibitors (ACE inhibitors) may result in hyperkalemia and cardiac arrhythmias or cardiac arrest.. Drug/Laboratory Test Interactions. Thyroid function tests may be altered by iodide.. Pregnancy. Category Dsee Warnings section. Nursing Mothers. Potassium iodide is excreted in breast milk. Use by nursing mothers may cause skin rash and thyroid suppression in the infant.. Pediatric Use. Safety and effectiveness in children have not been established.

WARNINGS SECTION.

Warnings. Potassium iodide can cause fetal harm, abnormal thyroid function, and goiter when administered to pregnant woman. Because of the possible development of fetal goiter, if the drug is used during pregnancy or if the patient becomes pregnant during therapy, apprise the patient of the potential hazard.