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Pepto-Bismol Original Liquid, Maximum Strength Liquid, Original and Cherry Tablets and Easy-To-Swallow Caplets (Procter & Gamble)



  • Description
  • Indications and Usage
  • Clinical Pharmacology
  • Warnings
  • Overdosage
  • Dosage and Administration
  • How Supplied



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  • Multi-symptom Pepto-Bismol® contains bismuth subsalicylate and is the only leading OTC stomach remedy clinically proven effective for both upper and lower GI symptoms. It has been clinically proven in double-blind placebo-controlled trials for relief of upset stomach symptoms and diarrhea.

    ACTIVE INGREDIENT

    (per tablespoon/per tablet/per caplet)

    Original Liquid/Tablets/Caplets

    Bismuth subsalicylate 262 mg

    Maximum Strength Liquid

    Bismuth subsalicylate 525 mg

    INACTIVE INGREDIENTS

    [Original Liquid]    benzoic acid, flavor, magnesium aluminum silicate, methylcellulose, red 22, red 28, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, water

    [Maximum Strength Liquid]    benzoic acid, flavor, magnesium aluminum silicate, methylcellulose, red 22, red 28, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, water

    [Original Tablets]    calcium carbonate, flavor, magnesium stearate, mannitol, povidone, red 27 aluminum lake, saccharin sodium, talc

    [Cherry Tablets]    adipic acid, calcium carbonate, flavor, magnesium stearate, mannitol, povidone, red 27 aluminum lake, red 40 aluminum lake, saccharin sodium, talc

    [Caplets]    calcium carbonate, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, red 27 aluminum lake, silicon dioxide, sodium starch glycolate.

    Other Information:

    Sodium Content

    Original Liquid--each Tbsp contains: sodium 6 mg · low sodium

    Maximum Strength Liquid--each Tbsp contains: sodium 6 mg · low sodium

    Chewable Tablets--each Original or Cherry Flavor Tablet contains: sodium less than 1 mg · very low sodium

    Caplets--each Caplet contains: sodium 2 mg · low sodium

    Salicylate Content

    Original Liquid--each Tbsp contains: salicylate 130 mg

    Maximum Strength Liquid--each Tbsp contains: salicylate 236 mg

    Chewable Tablets--each tablet contains:

    [original] salicylate 102 mg

    [cherry] salicylate 99 mg

    Caplets--each caplet contains: salicylate 99 mg

    All Forms are sugar free.

    INDICATIONS

    • relieves upset stomach symptoms (i.e., indigestion, heartburn, nausea and fullness caused by over-indulgence in food and drink) without constipating; and,
    • controls diarrhea.

    ACTIONS

    For upset stomach symptoms, the active ingredient is believed to work via a topical effect on the stomach mucosa. For diarrhea, it is believed to work by several mechanisms in the gastrointestinal tract, including: 1) normalizing fluid movement via an antisecretory merchanism, 2) binding bacterial toxins and 3) antimicrobial activity.

    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.

    Notes:    May cause a temporary and harmless darkening of the tongue or stool. Stool darkening should not be confused with melena.

    While no lead is intentionally added to Pepto-Bismol, this product contains certain ingredients that are mined from the ground and thus contain small amounts of naturally occurring lead. For example, bismuth, contained in the active ingredient of Pepto-Bismol, is mined and therefore contains some naturally occurring lead. The small amounts of naturally occurring lead in Pepto-Bismol are low in comparison to average daily lead exposure; this is for the information of healthcare professionals. Pepto-Bismol is indicated for treatment of acute upset stomach symptoms and diarrhea. It is not intended for chronic use.

    OVERDOSAGE

    In case of overdose, patients are advised to contact a physician or Poison Control Center. Emesis induced by ipecac syrup is indicated in large ingestions provided ipecac can be administered within one hour of ingestion. Activated charcoal should be administered after gastric emptying. Patients should be evaluated for signs and symptoms of salicylate toxicity.

    DIRECTIONS

    Pepto-Bismol® Original Liquid, Original & Cherry Flavor Chewable Tablets, and Caplets

    [Original Liquid]

    • shake well before using
    • for accurate dosing, use dose cup

    [Original Tablet, Cherry Tablets]

    • chew or dissolve in mouth

    [Caplets]

    • swallow with water, do not chew

    • adults and children 12 years and over: 1 dose (2 Tbsp or 30 ml; 2 tablets or 2 caplets) every 1/2 to 1 hour as needed
    • do not exceed 8 doses (16 Tbsp or 240 ml) 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

    Pepto-Bismol® Maximum Strength Liquid

    • shake well before use
    • for accurate dosing, use dose cup
    • adults and children 12 years and over: 1 dose (2 Tbsp 30 ml) every 1 hour as needed
    • do not exceed 4 doses (8 Tbsp or 120 ml) 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

    HOW SUPPLIED

    Pepto-Bismol® Original and Maximum Strength Liquids are pink. Pepto-Bismol® Original Liquid is available in: 4, 8, 12 and 16 fl oz bottles. Pepto-Bismol® Maximum Strength Liquid is available in: 4, 8 and 12 fl oz bottles. Pepto-Bismol® Original and Cherry Flavor Tablets are pink, round, chewable tablets imprinted with a debossed triangle and "Pepto-Bismol" on one side. Tablets are available in: boxes of 30 and 48. Pepto-Bismol® Caplets are pink and imprinted with "Pepto-Bismol" on one side. Caplets are available in bottles of 24 and 40.

    • avoid excessive heat (over 104°F or 40°C)
    • protect liquids from freezing

    Questions:    1-800-717-3786

    www.pepto-bismol.com








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    This page was last modified 30-JUN-07
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