Label: TREDA ULTRA- bismuth subsalicylate tablet

  • NDC Code(s): 83393-749-08
  • Packager: Laboratorios Sanfer, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 6, 2024

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  • Active ingredient (in each caplet)

    Bismuth subsalicylate 525 mg

  • Purpose

    Upset stomach reliever/antidiarrheal

  • Uses

    relieves

    • travelers’ diarrhea
    • diarrhea
    • upset stomach due to overindulgence in food and drink, including:
      • indigestion
      • fullness
      • gas
      • nausea
      • heartburn
      • belching
  • 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

    • gout
    • diabetes
    • arthritis
    • anticoagulation (thinning the blood)

    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.

  • Directions

    • do not take more than directed
    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • swallow with water; do not chew
    • adults and children 12 years and over: 1 caplet every 1/2 to 1 hour as needed. Do not exceed 8 caplets in 24 hours.
    • do not use for more than 2 days unless directed by a doctor
    • use until diarrhea stops, but not more than 2 days
    • children under 12 years: ask a doctor
  • Other information

    • each caplet contains: calcium 45 mg, salicylate 206 mg, sodium 3 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • avoid excessive heat
    • see end flap for expiration date and lot number
  • Inactive ingredients

    calcium carbonate, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

  • Questions or comments?

    Call 1-(833) 604-1084 (English and Spanish)
    8:00 AM-5:00 PM CST, Monday-Friday

  • Principal display panel

    Treda®
    Ultra

    Bismuth Subsalicylate 525 mg

    UPSET STOMACH RELIEVER
    ANTIDIARRHEAL

    RELIEVES:

     Diarrhea

    Nausea

    Heartburn

    Upset Stomach

    Indigestion

    Actual Size

    24
    caplets

    sanfer®

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    50844
    ORG032174908

    Manufactured for: Laboratorios Sanfer S.A. de C.V.
    Blvd. Adolfo López Mateos No. 314
    Col. Tlacopac, CDMX, 01049. México

    This product is produced in compliance with all United
    States regulatory and quality requirements for
    pharmaceutical product.

    Treda Ultra 44-749

    Treda Ultra 44-749

  • INGREDIENTS AND APPEARANCE
    TREDA ULTRA 
    bismuth subsalicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83393-749
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE525 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code 44;749
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83393-749-081 in 1 CARTON02/06/2024
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00802/06/2024
    Labeler - Laboratorios Sanfer, S.A. de C.V. (810007732)
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