KA PEC (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]

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KA PEC (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]
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NDC 53807-515-12
Set ID fdfbd304-d7a3-48f0-966c-23823a4399c9
Category HUMAN OTC DRUG LABEL
Packager Rij Pharmaceutical Corporation
Generic Name
Product Class
Product Number
Application Number PART335
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  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-515
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53807-515-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33503/16/1999
    Labeler - Rij Pharmaceutical Corporation (144679156)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rij Pharmaceutical Corporation144679156manufacture(53807-515)
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