Label: ESTOMAQUIL POLVO- bismuth subsalicylate powder

  • NDC Code(s): 58988-1080-1, 58988-1080-2, 58988-1080-3
  • Packager: ProMex LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each pouch)

    Bismuth Subsalicylate 262 mg

  • Purpose

    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 or 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 salicylate (including aspirin)
    • taking other salicylate products

    Do not use if you have

    • an ulcer
    • a bleeding problem

    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 the reach of children. In case of overdose, seek professional help or contact a poison control center immediately

  • Directions

    • Adults & Children 12 yrs and older: Dissolve 2 pouches (1 dose) in 1/2 glass of water. Repeat every 1/2 to 1 hour as needed, to a maximum of 8 doses in a 24-hour period
      • use until diarrhea stops, but not more than 2 days. If symptoms persist, consult a doctor
      • drink plenty of clear fluids to help prevent dehydration which may accompany diarrhea
    • Children under 12 yrs: ask a doctor
  • Other information

    • each pouch contains: calcium 210 mg, magnesium 190 mg, sodium 206 mg
    • avoid excessive heat
  • Inactive ingredients

    anhydrous citric acid, calcium carbonate, magnesium hydroxide, maltodextrin, silicon dioxide, sodium bicarbonate, tartaric acid

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    PRO-MEX®
    P.O. Box 63-0716
    Miami, FL. 33163

  • PRINCIPAL DISPLAY PANEL - 3.0 g Pouch Carton

    ESTOMAQUIL®

    Bismuth Subsalicylate 262 mg

    Relief for:

    • Nausea
    • Heartburn
    • Diarrhea
    • Fullness

    Maximum Strength

    10 Pouches
    0.1 oz (3.0 g) Each

    Principal Display Panel - 3.0 g Pouch Carton
  • INGREDIENTS AND APPEARANCE
    ESTOMAQUIL POLVO 
    bismuth subsalicylate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-1080
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    TARTARIC ACID (UNII: W4888I119H)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58988-1080-110 in 1 CARTON01/02/2004
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:58988-1080-220 in 1 CARTON01/02/2004
    21 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:58988-1080-350 in 1 CARTON01/02/2004
    31 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00801/02/2004
    Labeler - ProMex LLC (789974388)
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