Treda Ultra 44-749

SPL v3

SPL

SPL Set ID cfa7f37a-e18b-4929-b3a4-4126b0aa679a

Route

ORAL

Published

Effective Date 2026-02-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bismuth Cation (525 mg)

Inactive Ingredients

Calcium Carbonate Starch, Corn D&c Red No. 27 Aluminum Lake D&c Red No. 30 Magnesium Stearate Mannitol Microcrystalline Cellulose Povidone, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: 44;749 Shape: oval Color: pink Size: 19 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-02-06

Description

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever/antidiarrheal

Medication Information

Purpose

Upset stomach reliever/antidiarrheal

Description

Bismuth subsalicylate 525 mg

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

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

Do Not Use

if you have

an ulcer
a bleeding problem
bloody or black stool

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

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.

Active Ingredient (in Each Caplet)

Bismuth subsalicylate 525 mg

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)

Structured Label Content

Uses

relieves

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

Purpose

Upset stomach reliever/antidiarrheal

Warnings

Allergy alert: Contains salicylate. Do not take if you are

allergic to salicylates (including aspirin)
taking other salicylate products

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

Do Not Use (Do not use)

if you have

an ulcer
a bleeding problem
bloody or black stool

Other Information (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 (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (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

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Bismuth subsalicylate 525 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

fever
mucus in the stool

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking any drug for

gout
diabetes
arthritis
anticoagulation (thinning the blood)

Advanced Ingredient Data

[{"name": "BISMUTH CATION", "unii": "ZS9CD1I8YE", "classCode": "ACTIB", "strengthNumerator": "525", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CALCIUM CARBONATE", "unii": "H0G9379FGK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27 ALUMINUM LAKE", "unii": "ZK64F7XSTX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 30", "unii": "2S42T2808B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves travelers’ diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: indigestion fullness gas nausea heartburn belching", "Purpose": "Upset stomach reliever/antidiarrheal", "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", "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", "Do not use": "if you have an ulcer a bleeding problem bloody or black stool", "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", "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.", "Active ingredient (in each caplet)": "Bismuth subsalicylate 525 mg", "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)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:34.383656 · Updated: 2026-03-14T23:13:44.961646