Label: PEPTIC RELIEF ORIGINAL STRENGTH- bismuth subsalicylate liquid

  • 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 August 30, 2012

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  • Active ingredient (in each 15 mL Tablespoon)

    Bismuth subsalicylate 262 mg

  • Purposes

    Upset stomach reliever/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

    • shake well before use
    • for accurate dosing, use dose cup
    • adults and children 12 years and over: 1 dose (2 Tbsp or 30 mL) 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
  • Other information

    • each Tbsp contains: magnesium 5 mg, potassium 5 mg and sodium 5 mg
    • salicylate 123 mg
    • protect from freezing
    • sugar free
    • low sodium
    • store at 20°-25°C (68°-77°F)
    • does not meet USP requirements for pH
    • for health information visit www.more-info.info
  • Inactive ingredients

    D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gum

  • Questions or comments?

    1-800-719-9260

    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma        74146

  • Principal Display Panel

    Original Strength

    Stomach Relief

    Bismuth Subsalicylate 262 mg

    Antidiarrheal/Upset Stomach Reliever

    Protective Coating Action

    Soothing Relief for 5 Symptoms:

    • Upset Stomach
    • Indigestion
    • Heartburn
    • Nausea
    • Diarrhea

    Compare to active ingredient of Pepto-Bismol®

    NDC 54868-2898-0
    237 mL
    Stomach Relief Label

    Stomach Relief Label

  • INGREDIENTS AND APPEARANCE
    PEPTIC RELIEF  ORIGINAL STRENGTH
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2898(NDC:0113-0302)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH CATION262 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    SORBIC ACID (UNII: X045WJ989B)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPINK (viscous) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-2898-0237 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33512/11/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel(54868-2898)
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