Label: PEPT-ACHE- bismuth subsalicylate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 21, 2022

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

View All Sections
  • 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 finalpart33502/02/2000
    Labeler - JHK Inc dba American Safety & First Aid (867236309)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!