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
  • 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 December 23, 2019

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

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Bismuth Subsalicylate: Each pouch contains 262 mg

  • Purpose

    Upset Stomach reliever / Antidiarrheal

  • Uses

    Relieves:

    • upset stomach
    • indigestion
    • diarrhea
    • heartburn
    • nausea
  • 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 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
    • bleeding problem
    • bloody or black stool.

    Ask a doctor before use if you have

    • fever
    • mucus in stool.

    Ask a doctor or pharmacist before use if you are taking any drugs 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 ears or loss of hearing occurs
    • if 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 or older: Dissolve 2 pouches 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

    • Avoid excessive heat
    • Each pouch contains: sodium 223mg
  • Inactive Ingredients

    calcium carbonate, citric acid, magnesium hydroxide, sodium bicarbonate, tartaric acid

  • PRINCIPAL DISPLAY PANEL - 10 Packet Carton

    ESTOMAQUIL®

    Relief for:

    • Nausea
    • Heartburn
    • Diarrhea
    • Fullness

    Maximum Strength

    10 Packets

    PRINCIPAL DISPLAY PANEL - 10 Packet 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)  
    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 FINALpart33501/02/2004
    Labeler - ProMex LLC (789974388)