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
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Drug Label Information
Updated September 27, 2013
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- INACTIVE INGREDIENTS
- INDICATION
- DIRECTION
- USUAL ADULT DOSE
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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.
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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.
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PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC 16571-303-16
TAMPER EVIDENTPotassium Chloride
Oral Solution, USP10% Cherry Flavored
Sugar FreeRx 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 60089ONE PINT (473 mL)
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INGREDIENTS AND APPEARANCE
POTASSIUM CHLORIDE
potassium chloride liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16571-303 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152, Chloride Ion - UNII:Q32ZN48698) Potassium Chloride 40 meq in 30 mL Inactive Ingredients Ingredient Name Strength 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 Color PINK Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Business Operations Bio-Pharm, Inc. 801652546 MANUFACTURE(16571-303) , ANALYSIS(16571-303) , PACK(16571-303) , LABEL(16571-303)