Label: POTASSIUM CHLORIDE liquid

  • NDC Code(s): 16571-303-16
  • Packager: Pack Pharmaceuticals LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated September 27, 2013

If you are a consumer or patient please visit this version.

  • 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.

  • HOW SUPPLIED

    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)

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    POTASSIUM CHLORIDE 
    potassium chloride liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:16571-303
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152, Chloride Ion - UNII:Q32ZN48698) Potassium Chloride40 meq  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sorbitol (UNII: 506T60A25R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cherry (UNII: BUC5I9595W)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16571-303-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER09/23/2013
    Labeler - Pack Pharmaceuticals LLC (614823875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio-Pharm, Inc.801652546MANUFACTURE(16571-303) , ANALYSIS(16571-303) , PACK(16571-303) , LABEL(16571-303)