Potassium Chloride

Major Pharmaceuticals

Potassium Chloride Oral Solution, USP

FULL PRESCRIBING INFORMATION: CONTENTS*

• INACTIVE INGREDIENTS
• INDICATION
• DIRECTION
  • USUAL ADULT DOSE
• WARNINGS
• DRUG INTERACTION
• TOXICITY
• QUESTION
• PRINCIPAL DISPLAY PANEL - 473 mL Label

FULL PRESCRIBING INFORMATION

INACTIVE INGREDIENTS

citric acid, D&C Red #33, FD&C Red #40, glycerin, purified water, sodium benzoate, sodium saccharin, sorbitol solution, wild cherry flavor.

INDICATION

For treatment of patient with hypokalemia, with or without metabolic alkalosis, in digitalis intoxication.

DIRECTION

To minimize gastrointestinal irritation, patients must follow direction regarding dilution. Each tablespoonful (15mL) should be diluted with three (3) fluid ounce or more of water or other liquid.

USUAL ADULT DOSE

One (1) tablespoonful (15mL) twice daily (after morning or evening meals) supplies 40 mEq of potassium.

WARNINGS

Discontinue immediately if abdominal pain, distension, nausea, vomiting or gastrointestinal bleeding occurs. CONTRAINDICATED in the presence of dehydration or impaired kidney function. Potassium intoxication causes electrocardiographic abnormalities, flaccid paralysis of the skeletal muscles, paresthesias of the extremeties, listlessness, mental confusion, weakness and heaviness of the legs, fall in blood pressure, cardiac arrhythmias. Frequent checks of the clinical status of the patient, and periodic ECG and/or serum potassium levels should be made. Potassium intensifies the symptoms of myotonia congenita.

DRUG INTERACTION

Interaction with Potassium Sparing Diuretics: Hypokalemia should not be treated by the concomitant administration of potassium salts and potassium-sparing diuretics (e.g., spironolactone, triamterene or amiloride) since the simultaneous administration of these agents can produce severe hyperkalemia. Interaction with ACE inhibitors: Angiotensin converting enzyme (ACE) inhibitors (e.g., captopril, enlapril) will produce some potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors only with close monitoring.

TOXICITY

Hyperkalemia, when detected, must be treated immediately because lethal levels can be reached in a few hours.

Dispense in tight, light-resistant container as defined in USP/NF.

Store at 20°C-25°C (66° to 77°F). Avoid Freezing.

QUESTION

Adverse Drug Event: Call 800-616-2471

Manufactured by BIO-PHARM, Inc. Levittown, PA 19057 USA

M-64        Rev. 1008

PRINCIPAL DISPLAY PANEL - 473 mL Label

NDC 0904-1007-16
TAMPER-EVIDENT

Potassium
Chloride
Oral Solution,
USP

10% Cherry Flavored
Sugar Free
40 m Eq. Potassium per 30mL

Rx ONLY

Replacement therapy for
POTASSIUM-Deficiency States

To be used for oral administration only.

TAMPER-EVIDENT: Do not use this product
if inner foil seal over the mouth of the
bottle is cut, torn, broken or missing.

Distributed by
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA

ONE PINT (473 mL)

MAJOR^®
PHARMACEUTICALS