Active Ingredient (In Each Tablet)
Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)
Pep Tum Tablet, Chewable
FDA Label NDC 53117-046
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by First Aid Direct for the product Pep Tum (NDC 53117-046). 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 tablet), purpose, uses, reye’s syndrome, allergy alert, do not use if you have, ask a doctor or pharmacist before use if you, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antidiarrheal/Antacid
Uses
- controls diarrhea
- relieves heartburn, indigestion, nausea and upset stomach without constipating
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
- bloody or black stool
- an ulcer
- a bleeding problem
Ask A Doctor Or Pharmacist Before Use If You
- are taking any drug for anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
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
When Using This Product
a temporary, but harmless, darkening of the stool and/or tongue may occur.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, contact a doctor or Poison Control Center immediately.
Directions
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- Adults and Children 12 years and over: 525 mg (2 tablets) every ½ to 1 hour or 1050 mg (4 tablets) every hour as needed
- do not exceed 4200 mg ( 16 tablets) in 24 hours
- use until diarrhea stops but not more than 2 days
- Children under 12 years: ask a doctor
Inactive Ingredients
aspartame, calcium carbonate, , D&C red #27, dextrates, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide
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Pep Tum
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