Active Ingredient (In Each Caplet)
Bismuth subsalicylate 525 mg
Treda Ultra Tablet
FDA Label NDC 83393-749
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Sanfer, S.a. De C.v. for the product Treda Ultra (NDC 83393-749). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 1)
* Please review the disclaimer below.
