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Potassium Chloride Oral Solution

Pronunciation

Dosage Form: oral solution

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Potassium Chloride Oral Solution, USP

INACTIVE INGREDIENTS

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

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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 - 25°C (66 to 77°F). Avoid Freezing.

QUESTION

Adverse Drug Event: Call (866) 562-4597

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

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)

POTASSIUM CHLORIDE 
potassium chloride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16571-303
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Potassium Chloride (Potassium Cation and Chloride Ion) Potassium Chloride 40 meq  in 30 mL
Inactive Ingredients
Ingredient Name Strength
Anhydrous Citric Acid  
Sodium Benzoate  
Saccharin Sodium  
Sorbitol  
Glycerin  
Cherry  
D&C RED NO. 33  
FD&C RED NO. 40  
Water  
Product Characteristics
Color PINK Score     
Shape Size
Flavor CHERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:16571-303-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/23/2013
Labeler - Pack Pharmaceuticals LLC (614823875)
Establishment
Name Address ID/FEI Operations
Bio-Pharm, Inc. 801652546 MANUFACTURE(16571-303), ANALYSIS(16571-303), PACK(16571-303), LABEL(16571-303)
Revised: 09/2013
 
Pack Pharmaceuticals LLC



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