Label: SOOTHE- bismuth subsalicylate tablet

  • 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 January 25, 2017

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  • Active ingredient (in each caplet)

    Bismuth subsalicylate 262 mg 

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  • Purpose

    Upset stomach reliever/antidiarrheal 

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  • Uses

    relieves:

    • travelers' diarrhea
    • diarrhea
    • upset stomach due to overindulgence in food and drink, including:
      • heartburn
      • indigestion
      • nausea
      • gas
      • belching
      • fullness
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  • 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 alert: Contains salicylate. Do not take if you are:

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

    Do not use

    if you have

    • an ulcer
    • a bleeding problem
    • bloody or black stool 

    Ask a doctor before use if you have

    • fever
    • mucus in the stool 

    Ask a doctor or pharmacist before use if you are

    taking any drug for

    • anticoagulation (thinning the blood)
    • gout
    • diabetes
    • 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 (1-800-222-1222) right away.

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  • Directions

    • swallow with water, do not chew
    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed. Do not exceed 8 doses (16 caplets) in 24 hours. 
    • use until diarrhea stops, but not more than 2 days
    • children under 12 years: ask a doctor
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  • Other information

    • each caplet contains: calcium 20 mg, salicylate 103 mg
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid excessive heat
    • see end flap for expiration date and lot number 
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  • Inactive ingredients

    calcium carbonate, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid 

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  • Questions or comments?

     1-800-426-9391

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  • Principal Display Panel

    Well at
    Walgreens
    WALGREENS PHARMACIST RECOMMENDEDǂ

    NDC 0363-0346-10

    Soothe®
    Bismuth Subsalicylate 262 mg
    Upset Stomach Reliever / Antidiarrheal

    Multi-symptom relief of:
    • Nausea • Heartburn
    • Indigestion
    • Upset stomach
    • Diarrhea

    40 CAPLETS

    Actual Size

    Compare to Pepto-Bismol® active ingredientǂǂ

    ǂWalgreens Pharmacist Survey Study, November 2014.
    ǂǂThis product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Pepto-Bismol®.

    50844    REV1016B34610

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com      ©2016 Walgreen Co.

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
    Walgreens 44-346

    Walgreens 44-346


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  • INGREDIENTS AND APPEARANCE
    SOOTHE 
    bismuth subsalicylate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0346
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 262 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    Color PINK Score no score
    Shape OVAL Size 16mm
    Flavor Imprint Code 44;346
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0346-10 1 in 1 CARTON 05/06/2011
    1 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part335 05/06/2011
    Labeler - Walgreen Company (008965063)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(0363-0346)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(0363-0346)
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