POTASSIUM CHLORIDE- potassium chloride solution 
Westminster Pharmaceuticals, LLC

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.

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Potassium Chloride Oral Solution, USP 20%

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Potassium Chloride 20

INACTIVE INGREDIENT SECTION

Cherry flavor, D&C Red #33, FD&C Red #40, glycerine, methyl paraben, propylene glycol, propyl paraben, purified water, sodium citrate, sodium saccharin

DRUG INTERACTIONS SECTION

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 ºC (66 º to 77 ºF) Avoid Freezing.

DOSAGE AND ADMINISTRATION SECTION

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

Usual Adult Dose: one (1) tablespoon (15 mL) twice daily (after morning or evening meals) supplies 80 mEq of Potassium.

INDICATIONS AND USAGE SECTION

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

WARNINGS AND PRECAUTIONS SECTION

Discontinue immediatly if abdominal pain, distension, nausea, vomiting or gastrointestinal bleeeding occurs. CONTRAINDICATED in the ;presence of dehydration or impaired kidney function. Potassium iantoxication causes electrocardiographic abnormalities, flaccid paraysis of the skeletal muscles, paresthesias of the extremities, listlessness, mental confusion, weakness and heaviness of the legs, fall in blood pressure, cardiac arrhymias. 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.

POTASSIUM CHLORIDE 
potassium chloride solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69367-102
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
potassium chloride (UNII: 660YQ98I10) (potassium cation - UNII:295O53K152) potassium cation2.6 meq  in 1 mL
Inactive Ingredients
Ingredient NameStrength
sorbitol (UNII: 506T60A25R)  
glycerin (UNII: PDC6A3C0OX)  
water (UNII: 059QF0KO0R)  
saccharin sodium dihydrate (UNII: SB8ZUX40TY)  
citric acid monohydrate (UNII: 2968PHW8QP)  
D&C Red No. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69367-102-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/22/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/22/201510/02/2015
Labeler - Westminster Pharmaceuticals, LLC (079516651)

Revised: 10/2015
 
Westminster Pharmaceuticals, LLC