Active Ingredient ( In Each Caplet)
Bismuth subsalicylate 525 mg
Anti-diarrheal
FDA Label NDC 49035-769
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Anti-diarrheal (NDC 49035-769). 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
Antidiarrheal
Uses
relieves
- traveler's diarrhea
- diarrhea
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 chances 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
- anticoagulation (thinning the blood)
- gout
- diabetes
- 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 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
- 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 hour or 2 caplets every hour as needed
- do not exceed 8 caplets in 24 hours
- 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
- use by expiration date on package
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?
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NDC 49035-769-08
Compare to the active ingredient in Pepto® Diarrhea*
MAXIMUM STRENGTH
Anti-Diarrheal
Bismuth subsalicylate 525 mg
Anti-Diarrheal
Relieves Diarrhea
Actual Size
525 mg EACH
24 CAPLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY: Walmart inc., Bentonville, AR 72716
*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Pepto® Diarrhea.
50844 ORG121974908
Equate 44-749 (Equate 44 749 1)
* Please review the disclaimer below.
