SSKI ® Potassium Iodide Oral Solution, USP (Saturated) 1 g/mL

Manufacturer
Avondale Pharmaceuticals, LLC
Effective date
2025-07-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 21:37:20

Label at a glance#

ProductSSKI
Active ingredientPotassium Iodide
Label structure13 sections

Indications and uses

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

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx only

Description

DESCRIPTION SECTION

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 SECTION

Potassium iodide is thought to act as an expectorant by increasing respiratory tract secretions and thereby decreasing the viscosity of mucus.

Indications and Usage

INDICATIONS & USAGE SECTION

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.

Contraindications

CONTRAINDICATIONS SECTION

Contraindicated in patients with a known sensitivity to iodides.

Warnings

WARNINGS SECTION

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.

Precautions

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

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

DRUG INTERACTIONS SECTION

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

DRUG & OR LABORATORY TEST INTERACTIONS SECTION

Thyroid function tests may be altered by iodide.

Pregnancy

PREGNANCY SECTION

see "Warnings" section.

Nursing Mothers

NURSING MOTHERS SECTION

Potassium iodide is excreted in breast milk. Use by nursing mothers may cause skin rash and thyroid suppression in the infant.

Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness in children have not been established.

Adverse Reactions

ADVERSE REACTIONS SECTION

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.

Overdosage

OVERDOSAGE SECTION

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.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Adults

SPL UNCLASSIFIED SECTION

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.

How Supplied

HOW SUPPLIED SECTION

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.

STORAGE AND HANDLING SECTION

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.

SPL UNCLASSIFIED SECTION

Manufactured for
Avondale Pharmaceuticals, LLC
Birmingham, AL 35209

112886-02

Revised 0420

© 2020 Avondale Pharmaceuticals, LLC

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71740-112-30

SSKI®

Potassium Iodide
Oral Solution, USP
(saturated)

1 g/mL

1 Fluid Oz.
(30 mL)
Rx only

AVONDALE

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312541potassium iodide 1 GM in 1 mL Oral SolutionPSN7
544597SSKI 1 GM in 1 mL Oral SolutionPSN7
544597potassium iodide 1000 MG/ML Oral Solution [SSKI brand of Potassium Iodide]SBD7
312541potassium iodide 1000 MG/ML Oral SolutionSCD7
312541K+ Iodide 1000 MG/ML Oral SolutionSY7
544597K+ Iodide 1000 MG/ML Oral Solution [SSKI brand of Potassium Iodide]SY7
312541Pot Iodide 1000 MG/ML Oral SolutionSY7
544597Pot Iodide 1000 MG/ML Oral Solution [SSKI brand of Potassium Iodide]SY7
312541potassium iodide 1 GM per 1 ML Oral SolutionSY7
544597SSKI 1 GM per 1 ML Oral SolutionSY7
544597SSKI brand of Potassium Iodide 1 GM per 1 ML Oral SolutionSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71740-112-08SSKI1 in 1 CARTONSOLUTION17
71740-112-08SSKI237 mL in 1 BOTTLESOLUTION2377
71740-112-30SSKI30 mL in 1 BOTTLE, WITH APPLICATORSOLUTION307
71740-112-30SSKI1 in 1 CARTONSOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71740-112-08ML - Milliliter71740-112aacc6625-4b13-4238-8f92-441e389b480912017-12-14
71740-112-30ML - Milliliter71740-1129a15cfe6-bc92-45fb-85e3-e1fe8fafe52912017-12-14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71740-11271740-112-30, 71740-112-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Potassium Iodide1C4QK22F9JACTIB
sodium thiosulfateHX1032V43MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SSKIPOTASSIUM IODIDEAvondale Pharmaceuticals, LLCca1d3449-ea29-49a4-8863-365ec95f15532025-07-09Warnings, Adverse reactionsExact identifier
ndc (package): 71740-112-08
ndc (package): 71740-112-30
ndc (product): 71740-112
ndc11 (package): 71740011208
ndc11 (package): 71740011230
spl id: 6a232f5f-b029-4908-98b1-eda6ab98f451
spl set id: ca1d3449-ea29-49a4-8863-365ec95f1553

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.