PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

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DESCRIPTION SECTION

Description

SSKI ®(potassium iodide oral solution, USP) is a saturated solution of potassium iodide containing 1 gram of potassium iodide per mL.

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INDICATIONS & USAGE SECTION

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.

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PRECAUTIONS SECTION

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.

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HOW SUPPLIED SECTION

How Supplied

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.

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.

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SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 NE 16TH PL

MIAMI, FL 33179

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