Official product label reference
Sski — Avondale Pharmaceuticals, LLC
This page contains 18 source sections for POTASSIUM IODIDE, oral route. Label set ca1d3449-ea29-49a4-8863-365ec95f1553, version 7.
Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label
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 and Usage SSKI ® (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.
Dosage and administration — label text
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 3 to 4 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.
Contraindications
Contraindications Contraindicated in patients with a known sensitivity to iodides.
Warnings
Warnings Potassium iodide can cause fetal harm, abnormal thyroid function, and goiter when administered to a 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.
Adverse reactions
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.
Drug interactions
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.
Unclassified section
Rx only
Manufactured for Avondale Pharmaceuticals, LLC Birmingham, AL 35209 112886-02 Revised 0420 © 2020 Avondale Pharmaceuticals, LLC
Product description
Description SSKI ® (potassium iodide oral solution, USP) is a saturated solution of potassium iodide containing 1 gram of potassium iodide per mL.
Clinical pharmacology
Clinical Pharmacology Potassium iodide is thought to act as an expectorant by increasing respiratory tract secretions and thereby decreasing the viscosity of mucus.
Precautions
Precautions General In some patients, prolonged use of iodides can lead to hypothyroidism. Iodides should be used with caution in patients having Addison's 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 see " 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.
General precautions
General In some patients, prolonged use of iodides can lead to hypothyroidism. Iodides should be used with caution in patients having Addison's disease, cardiac disease, hyperthyroidism, myotonia congenita, tuberculosis, acute bronchitis, or renal function impairment.
Drug and or laboratory test interactions
Drug/Laboratory Test Interactions Thyroid function tests may be altered by iodide.
Pregnancy
Pregnancy see " Warnings " section.
Breastfeeding
Nursing Mothers Potassium iodide is excreted in breast milk. Use by nursing mothers may cause skin rash and thyroid suppression in the infant.
Children and adolescents
Pediatric Use Safety and effectiveness in children have not been established.
Overdose information
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.
Supply and packaging
How Supplied SSKI ® (potassium iodide oral solution, USP) is supplied in 1 fluid ounce (30 ml) bottles (NDC 71740-112-30) with a calibrated dropper marked to deliver 0.3 ml (300 mg) and 0.6 ml (600 mg); and 8 fluid ounce (237 ml) bottles (NDC 71740-112-08). Inactive ingredient: Sodium thiosulfate as a preservative. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [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.
Storage and handling
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [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.
Official sources and product identifiers
- DailyMed — complete source labelVerify the current version and original formatting, including tables and diagrams.
- openFDA — structured source recordMachine-readable label source, linked by the exact label set ID.
Substances listed: POTASSIUM IODIDE
RxNorm identifiers: 312541, 544597
Package NDC codes
71740-112-30, 71740-112-08
Further research and background
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Coverage and corrections
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.
Source retrieved 2026-10-02. Read the source policy.