Potassium Iodide Oral Solution, USP (Saturated)

Manufacturer
Emerald Therapeutics, LLC
Effective date
2026-08-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-01 13:09:40

Label at a glance#

ProductPotassium Iodide (Saturated)
Active ingredientPotassium Iodide
Label structure13 sections

Indications and uses

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

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

1 g/mL

Rx only

Description

DESCRIPTION SECTION

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

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 PRECAUTIONS SECTION

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 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.

DRUG & OR LABORATORY TEST INTERACTIONS SECTION

Drug/Laboratory Test Interactions: Thyroid function tests may be altered by iodide.

PREGNANCY SECTION

Pregnancy: see "Warnings" section.

NURSING MOTHERS 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 SECTION

Pediatric Use: 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– 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

Potassium iodide oral solution, USP is supplied in 1 fluid ounce (30 mL) bottles (NDC 72919-728-30) with a calibrated dropper marked to deliver 0.3 mL (300 mg). 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 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
Emerald Therapeutics, LLC
Birmingham, AL 35209

728111 REV. 0826

© 2026 Emerald Therapeutics, LLC

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72919-728-30

Potassium Iodide
Oral Solution, USP
(saturated)

1 g/mL

1 Fluid Oz.
(30 mL)

Rx only

EMERALD
THERAPEUTICALS, LLC

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130372919728307GTIN-13: 0372919728307
EAN-13: 0372919728307
GTIN-12: 372919728307
UPC-A: 372919728307
GTIN storage (14 digits): 00372919728307
potassium-01.jpg

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
72919-72872919-728-30

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-08-25daily-update2026-08-28 00:04:00

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
Potassium Iodide (Saturated)POTASSIUM IODIDEEmerald Therapeutics, LLC0bdf305f-ed4a-49d1-8901-edaed8d678502026-08-25Warnings, Adverse reactionsExact identifier
ndc (package): 72919-728-30
ndc (product): 72919-728
ndc11 (package): 72919072830
spl id: 082eb221-e9d4-4638-b97b-6ef337cd368d
spl set id: 0bdf305f-ed4a-49d1-8901-edaed8d67850

Reported adverse events (FAERS/openFDA)#

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