Active Ingredient (In Each Chewable Tablet)
Bismuth subsalicylate 262 mg
Pepto Bismol Tablet, Chewable
FDA Label NDC 58933-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Procter & Gamble Manufactura S De Rl De Cv for the product Pepto Bismol (NDC 58933-002). 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 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, 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 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.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• fully chew or dissolve in mouth before swallowing
• adults and children 12 years and over:
• 2 chewable tablets (1 dose) every 1/2 hour to 1 hour or 4 chewable tablets (2 doses) every hour as needed for diarrhea
• 2 chewable tablets (1 dose) every 1/2 hour to 1 our as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
• do not exceed 8 doses (16 chewable 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 chewable tablet contains:
- calcium 140 mg, magnesium 10 mg
- salicylate 101 mg
- low sodium
- Store at no greater than 77°F. Avoid excessive heat (over 104°F.)
Inactive Ingredients
adipic acid, calcium carbonate, D&C Red No 27 Aluminum Lake, FD&C Red No 40 Aluminum Lake, Flavors, magnesium stearate, mannitol, povidone, saccharin sodium, talc, water
Questions?
1-800-717-3786
Other
TAMPER EVIDENT: DO NOT USE IF THE PRINTED INNER WRAP IS BROKEN OR MISSING.
MADE IN MEXICO
DIST. BY PROCTER & GAMBLE
CINCINNATI, OH 45202
Principal Display Panel - 12 Chewable Tablets Carton
Pepto
Bismol
®
CHEWABLES
Bismuth Subsalicylate
Upset Stomach Reliever/ Antidiarrheal
TRAVEL SIZE
FAST 5 SYMPTOM RELIEF
NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA
12 CHEWABLE TABLETS
002 (002)
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