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Ka Pec (Rij Pharmaceutical Corporation)

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LIQUID 355 mL in 1 BOTTLE (53807-515-12) Label Information

Complete Ka Pec Information

  • Active ingredient (in each tablespoon= 15 mL)

    Bismuth subsalicylate 262 mg


  • Purpose

    Anti-diarrheal


  • Uses

    • controls diarrhea
    • reduce number of bowel movements
    • help firm stool

  • Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from children pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert:  Contains salicylate. Do not take  if you are

    • allergic to salicylates (including aspirin)
    • taking other salicylate products

    Do not use
    • if you have bloody or black stool
    • if you have an ulcer or bleeding problem

    Ask a doctor before use if you have
    • fever
    • mucus in the stool
    • a magnesium-restricted diet
    • a sodium-restricted diet

    Ask a doctor or pharmacist before use if you are
    • taking any drug for
    • anticoagulation (thinning the blood)
    • diabetes
    • gout
    • arthritis

    When using this product

    a temporary, but harmless darkening of the stool and/or tongue may occur

    Stop use and ask a doctor if
    • symptoms get worse
    • ringing in the ears or loss of hearing occurs
    • diarrhea lasts more than 2 days

    If pregnant or breast-feeding,

    ask a health professional before use.


  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center  right away.


  • Directions

    • Drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • shake well before using
    • repeat dosage every 1/2 to 1 hour as needed
    • do not take more than 8 doses in 24 hours
    • use until diarrhea stops but not more than 2 days
    • adults & children 12 years and over: 2 tablespoons (30 mL)
    • children under 12 years: ask a doctor

  • Inactive ingredients

    Carboxymethylcellulose sodium, flavor, glycerin, magnesium aluminum silicate, saccharin sodium, salicylic acid, sodium benzoate, sodium saliycylate, sorbitol, water


  • Other information

    • Store at room temperature. Protect from freezing and excessive heat (over 40oC or 104oF)
    • each tablespoon (15 mL) contains: magnesium 32 mg
    • each tablespoon (15 mL) contains: sodium 24 mg
    • TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

  • Principal Display Panel

    Bismuth label


  • INGREDIENTS AND APPEARANCE
    KA PEC  
    bismuth subsalicylate liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53807-515
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 262 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color pink Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53807-515-12 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/16/1999
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part335 03/16/1999
    Labeler - Rij Pharmaceutical Corporation (144679156)
    Establishment
    Name Address ID/FEI Business Operations
    Rij Pharmaceutical Corporation 144679156 manufacture(53807-515)