Label: PEPT-ACHE- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 73598-1232-1
  • Packager: JHK Inc dba American Safety & First Aid
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 24, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (In Each Tablet)

    Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)

  • Purpose

    Antidiarrheal/Antacid

  • Use

    temporarily relieves:

    • controls diarrhea
    • relieves heartburn, indigestion, nausea and upset stomach without constipating
  • Warnings

    Reye's Syndrome

    Children and teenagers who have or are recovering from chicken 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 Warning

    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
    • an ulcer
    • a bleeding problem

    Ask a doctor before use if you have

    • fever
    • mucus in the stool

    Ask a doctor or pharmacist before use if you are taking a prescription drug for:

    • anticoagulation (thinning of the blood)
    • diabetes
    • gout
    • arthritis

    Stop use and ask a doctor if

    • symptoms get worse
    • ringing in the ears or loss of hearing occurs
    • diarrhea lasts more than two days

    When using this product: a temporary, but harmless darkening of the stool and/or tongue may occur.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center right away.

  • Directions

    • do not use more than directed
    • chew or dissolve in mouth
    • use until diarrhea stops but not more than 2 days
    • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
    • do not exceed 16 tablets in 24 hours Adults and children: (12 years and older) Chew 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed

    Children under 12 years: ask a doctor

  • Other information

    • phenylketonurics: contains phenylalanine 1.1mg per tablet
    • each tablet contains 73mg elemental calcium
    • store at room temperature 59º-86ºF (15º-30ºC)
    • tamper-evident sealed packets do not use if packet is opened or torn
  • Inactive ingredients

    acacia gum, aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide

  • Questions?

    1-866-651-3660 Monday-Friday 8:00am-5:00pm EST

  • PRINCIPAL DISPLAY PANEL - 36 Tablet Packet Box

    This product is not manufactured or distributed by Proctor & Gamble
    Owner of the registered trademark Pepto-Bismol®.

    Pept-Ache

    Anti-Diarrheal

    • Temporary relief from upset stomach
    • Soothes nausea, heartburn and
      indigestion
    • Chewable tablets

    These quality comfort tablets are formulated and packaged for use in
    the workplace and meet ANSI Z308. 1-2015 standards. They are
    sealed in tamper-evident packets for safety and convenience.

    36 Tablets • 1 Tablet Per Packet

    PRINCIPAL DISPLAY PANEL - 36 Tablet Packet Box
  • INGREDIENTS AND APPEARANCE
    PEPT-ACHE 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73598-1232
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DEXTRATES (UNII: G263MI44RU)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize13mm
    FlavorPEPPERMINTImprint Code RH046
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73598-1232-136 in 1 BOX02/02/2000
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00802/02/2000
    Labeler - JHK Inc dba American Safety & First Aid (867236309)
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