Pepto Bismol Tablet, Chewable
FDA Label NDC 67751-155
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Navajo Manufacturing Company Inc. for the product Pepto Bismol (NDC 67751-155). 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 drug facts, active ingredient (in each chewable tablet), purpose, uses, warnings, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking any drug for, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Chewable Tablet)
Bismuth subsalicylate 262 mg
Purpose
Upset stomach reliever and antidiarrheal
Uses
Relieves
• travelers' diarrhea
• diarrhea
• upset stomach due to overindulgence in food and drink, including:
• heartburn • indigestion • nausea
• gas • belching • fullness
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
• anticoagulation (thinning the blood)
• diabetes
• gout
• 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 or last more than 2 days
• 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
• chew or dissolve in mouth
• adults and children 12 years and over:
• 2 tablets every 1/2 to 1 hour as needed
• do not exceed 8 doses (16 tablets) in 24 hours
• use until diarrhea stops but not more than 2 days
• children under 12 years: ask a doctor
• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Other Information
• each tablet contains:
• calcium 140 mg
• magnesium 9 mg
• salicylate 101 mg
• very low sodium
• protect from freezing
• avoid excessive heat (over 104°F or 40°C)
• do not use if pouch is opened
Inactive Ingredients
calcium carbonate, D&C red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc
Questions?
1-800-717-3786
Package Labeling:
Pepto (Pepto)
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