FDA.reportPublic FDA data

Treda Ultra

Manufacturer
Laboratorios Sanfer, S.A. de C.V.
Effective date
2026-02-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:45:49

Label at a glance#

ProductTreda Ultra
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever/antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for

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

When using this product

OTC - WHEN USING SECTION

a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

Principal display panel

PACKAGE LABEL.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1998447bismuth subsalicylate 525 MG Oral TabletPSN3
1998447bismuth subsalicylate 525 MG Oral TabletSCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BISMUTH CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850036904939GTIN-13: 0850036904939
EAN-13: 0850036904939
GTIN-12: 850036904939
UPC-A: 850036904939
GTIN storage (14 digits): 00850036904939		treda-ultra-44-749-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83393-749-08Treda Ultra1 in 1 CARTONTABLET13
83393-749-08Treda Ultra24 in 1 BOTTLE, PLASTICTABLET243

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83393-74983393-749-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CALCIUM CARBONATEH0G9379FGKIACT
STARCH, CORNO8232NY3SJIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
D&C RED NO. 302S42T2808BIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Treda UltraBISMUTH SUBSALICYLATELaboratorios Sanfer, S.A. de C.V.cfa7f37a-e18b-4929-b3a4-4126b0aa679a2026-02-12WarningsExact identifier
ndc (package): 83393-749-08
ndc (product): 83393-749
ndc11 (package): 83393074908
spl id: bf8d9411-58f5-4b37-8af1-6b7142172ef2
spl set id: cfa7f37a-e18b-4929-b3a4-4126b0aa679a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.