Label: EQUALINE STOMACH RELIEF- bismuth subsalicylate suspension

  • NDC Code(s): 41163-600-34, 41163-600-40
  • Packager: Supervalu Inc
  • 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 July 14, 2016

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

  • Active ingredient (in each 30 mL)

    Bismuth subsalicylate 1050 mg

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  • Purposes

    Upset stomach reliever and 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)
    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

    diarrhea lasts more than 2 days
    symptoms get worse
    ringing in the ears or loss of hearing occurs

    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).

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  • Directions

    shake well before use
    only use the dose cup provided
    adults and children 12 years and over: 1 dose (30 mL) every hour as needed
    do not exceed 4 doses (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
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  • Other information

    each 30 mL contains: magnesium 15 mg, potassium 5 mg and sodium 12 mg
    salicylate 461 mg
    low sodium
    store at 20-25°C (68-77°F). Avoid excessive heat over 104°F (40°C).
    protect from freezing
    does not meet USP requirements for pH
    for health information visit www.more-info.info
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  • Inactive ingredients

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

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  • Questions or comments?

    1-877-932-7948

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  • Principal Display Panel

    compare to Pepto-Bismol® Max Strength active ingredient

    maximum strength

    stomach relief liquid

    bismuth subsalicylate

    1050mg per 30mL

    (upset stomach reliever/anti-diarrheal)

    5 symptom digestive relief

    heartburn

    indigestion

    nausea

    upset stomach

    diarrhea

    12 FL OZ (355mL)

    Equaline Stomach Relief Liquid image
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  • INGREDIENTS AND APPEARANCE
    EQUALINE STOMACH RELIEF 
    bismuth subsalicylate suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-600
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 1050 mg  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    SORBIC ACID (UNII: X045WJ989B)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color PINK (viscous) Score     
    Shape Size
    Flavor WINTERGREEN Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41163-600-34 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/07/2004
    2 NDC:41163-600-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/22/2004
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part335 10/07/2004
    Labeler - Supervalu Inc (006961411)
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