Active Ingredient (In Each Soft Chewable Tablet)
Bismuth subsalicylate 262 mg
Pepto Bismol Fast Melts Tablet, Chewable
FDA Label NDC 69423-832
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Pepto Bismol Fast Melts (NDC 69423-832). 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 soft chewable tablet), purpose, uses, warnings, do not use if, 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 before swallowing
- adults and children 12 years and over:
- do not exceed 8 doses (16 soft 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
• 2 soft chewable tablets every 1/2 hour or 4 soft chewable tablets every hour as needed for diarrhea
• 2 soft chewable tablets every 1/2 hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
Other Information
- each soft chewable tablet contains: • calcium 55 mg • salicylate 100 mg • low sodium
- Store at no greater than 25°C. Avoid excessive heat (over 40°C).
Inactive Ingredients
calcium carbonate, carrageenan, corn syrup, FD&C Blue No. 1, FD&C Red No. 40, flavor, hydrogenated coconut oil, soy lecithin, sucrose, water
Questions?
1-800-717-3786
Other
TAMPER EVIDENT: DO NOT USE IF INNER PRINTED SEAL ON BOTTLE IS BROKEN OR MISSING.
DIST. BY: PROCTER & GAMBLE,
CINCINNATI, OH 45202
Principal Display Panel - 24 Soft Chewable Tablets
Pepto Bismol®
Bismuth Subsalicylate
Upset Stomach Reliever/Antidiarrheal
FAST MELTS
COATS & COOLS
WINTER FROST FLAVORED
24 SOFT CHEWABLE TABLETS
832.jpg (832)
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