Prescription Drug Name:

Potassium Chloride Oral Solution, USP

ID:

7aa46114-6955-4568-a40a-bceddb47d38d

Code:

34391-3

INACTIVE INGREDIENTS


id: e5da99d3-f93d-4aa6-913f-c94a0a1e2451
displayName: INACTIVE INGREDIENT SECTION
FDA Article Code: 51727-6

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

INDICATION


id: 9e6dff84-8ecd-408e-a23b-d95a095ceefc
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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

DIRECTION


id: 6dbc81f8-45a8-406f-ba2b-8173f2df62e2
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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


id: 83131aff-84f0-4703-84a0-c645d6a5c7d8
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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

WARNINGS


id: ec8aa1b6-5f89-435a-843c-7a8983b168af
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

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


id: acc3cd90-d8d5-48ee-b946-923d39925140
displayName: DRUG INTERACTIONS SECTION
FDA Article Code: 34073-7

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


id: 34dfbebb-16be-4332-9af7-d7efac7aa65f
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

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

QUESTION


id: 79e0cb77-86ad-46be-9d4b-9bbb2981a195
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

Adverse Drug Event: Call (866) 562-4597

PRINCIPAL DISPLAY PANEL – 473 mL Bottle Label


id: f06bcb50-e20f-44ea-88fb-d46c5f75687e
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 16571-303-16
TAMPER EVIDENT
Potassium Chloride
Oral Solution, USP
10% Cherry Flavored
Sugar Free
Rx only 40 m Eq. Potassium per 30mL 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.
Manufactured by:
Bio-Pharm, Incorporated Levittown, PA 19057
Distributed by:
PACK™
Pharmaceuticals

PACK Pharmaceuticals, LLC Buffalo Grove, IL 60089 ONE PINT (473 mL)