POTRASSIUM CHLORIDE- potassium chloride solution 
Major Pharmaceuticals

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 10%

INACTIVE INGREDIENTS

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

INDICATION

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

DIRECTIONS

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.

QUESTIONS OR COMMENTS?

(800) 616-2471

Manufactured by Pharmatech LLC
Davie, FL 33314 USA

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

M-133
CT20016L Rev. 06/14

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 0904-6414-16

TAMPER-EVIDENT
Potassium
Chloride
Oral Solution,
USP 10%
Cherry Flavored
Sugar Free

40 mEq. 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.

ONE PINT (473 mL)

MAJOR®

Principal Display Panel - 473 mL Bottle Label
POTRASSIUM CHLORIDE 
potassium chloride solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0904-6414
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION40 meq  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
D&C Red No. 33 (UNII: 9DBA0SBB0L)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6414-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER07/23/201406/16/2015
Labeler - Major Pharmaceuticals (191427277)

Revised: 12/2015
Document Id: b907f136-44a5-4211-9588-d0508e865941
Set id: f3ecb7f6-fe28-49bd-990b-187c5ea5d298
Version: 2
Effective Time: 20151211
 
Major Pharmaceuticals