GOOD SENSE STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [L. PERRIGO COMPANY]

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GOOD SENSE STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [L. PERRIGO COMPANY]
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NDC 0113-0469-65, 0113-0469-91
Set ID 8aa42c4a-42f2-4487-bce3-0c755b9bad4c
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number PART335
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  • Active ingredient (in each tablet)

    Bismuth subsalicylate 262 mg

  • Purposes

    Upset stomach reliever and antidiarrheal

  • Uses

    relieves

    •
    travelers’ diarrhea
    •
    diarrhea
    •
    upset stomach due to overindulgence in food and drink, including:
    •
    heartburn
    •
    indigestion
    •
    nausea
    •
    gas
    •
    belching
    •
    fullness
  • 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)
    •
    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 (1-800-222-1222).

  • Directions

    •
    chew or dissolve in mouth
    •
    adults and children 12 years and over: 2 tablets every ½ to 1 hour as needed
    •
    do not exceed 8 doses (16 tablets) in 24 hours
    •
    use until diarrhea stops but not more than 2 days
    •
    children under 12 years: ask a doctor
    •
    drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • Other information

    •
    each tablet contains: calcium 190 mg
    •
    salicylate 104 mg
    •
    very low sodium
    •
    store at 20-25°C (68-77°F). Avoid excessive heat over 104°F (40°C).
  • Inactive ingredients

    calcium carbonate, D&C red #27 aluminum lake, flavor, magnesium stearate, mannitol, saccharin sodium, stearic acid

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    GREAT SIZE FOR TRAVEL

    Compare to Pepto-Bismol® active ingredient

    stomach relief tablets

    Bismuth Subsalicylate 262 mg

    UPSET STOMACH RELIEVER / ANTI-DIARRHEAL

    5 Symptom Digestive Relief

    Heartburn - Indigestion

    Nausea

    Upset Stomach

    Diarrhea

    actual size

    6 CHEWABLE TABLETS

    GoodSense Stomach Relief Tablets image
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE STOMACH RELIEF 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0469
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize17mm
    FlavorImprint Code L469
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0469-6530 in 1 CARTON08/24/1993
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:0113-0469-916 in 1 CARTON08/10/2016
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33508/24/1993
    Labeler - L. Perrigo Company (006013346)
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