SSKI

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2025-05-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 21:34:04

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

NDC 17856-0114-01 (potassium iodide oral solution, USP) is supplied in 0.1G/0.1mL 120 Syringes

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

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 NE 16TH PL

MIAMI, FL 33179

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312541potassium iodide 1 GM in 1 mL Oral SolutionPSN5
312541potassium iodide 1000 MG/ML Oral SolutionSCD5
312541K+ Iodide 1000 MG/ML Oral SolutionSY5
312541Pot Iodide 1000 MG/ML Oral SolutionSY5
312541potassium iodide 1 GM per 1 ML Oral SolutionSY5

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0114-1SSKI120 in 1 BOX, UNIT-DOSESOLUTION1205
17856-0114-1SSKI0.1 mL in 1 SYRINGESOLUTION0.15
17856-0114-2SSKI120 in 1 BOX, UNIT-DOSESOLUTION1205
17856-0114-2SSKI0.1 mL in 1 SYRINGESOLUTION0.15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0114-1EA - Each17856-01140f1927fa-12dc-4ce5-a7eb-7616a62a0c7412025-07-08
17856-0114-2EA - Each17856-01147ecef745-cb6c-4498-bc04-ef97680a978012025-07-08
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
17856-011417856-0114-1, 17856-0114-2
71740-112

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
SODIUM THIOSULFATEHX1032V43MIACT
POTASSIUM IODIDE1C4QK22F9JACTIB

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 · 2 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 (product): 71740-112
SSKIPOTASSIUM IODIDEATLANTIC BIOLOGICALS CORP.664e6cd9-6a3c-49ef-a7b2-d09f0338b5492025-05-28Warnings, Adverse reactionsExact identifier
ndc (package): 17856-0114-2
ndc (package): 17856-0114-1
ndc (product): 17856-0114
ndc11 (package): 17856011402
ndc11 (package): 17856011401
spl id: 36341581-eb16-560d-e063-6394a90afb4a
spl set id: 664e6cd9-6a3c-49ef-a7b2-d09f0338b549

Reported adverse events (FAERS/openFDA)#

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