PEPTO BISMOL- bismuth subsalicylate tablet, chewable

Pepto Bismol by

Drug Labeling and Warnings

Pepto Bismol by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

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:
•      2 chewable tablets every ½ hour or 4 chewable tablets every hour as needed for diarrhea
•      2 chewable tablets every ½ hour to 1 hour 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 50 mg salicylate 117 mg
• low sodium
• Store at no greater than 25°C. Avoid excessive heat (over 40°C.)

Inactive ingredients

acacia, anhydrous citric acid, calcium carbonate, caprylic/capric triglyceride, carmine, carnauba wax, corn starch, corn syrup, dextrin, FD&C Blue No. 2 Aluminum Lake, flavors, hydrogenated coconut oil, maltodextrin, potassium hydroxide, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, water, white wax

Questions?

1-800-717-3786

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 70 Chewable Tablets

Pepto Bismol

Bismuth Subsalicylate -

Upset Stomach Reliever/ Antidiarrheal

CHEWS

BERRY MINT FLAVORED

NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA

70 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

PEPTO BISMOL 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-321
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBIC ACID (UNII: X045WJ989B)
SORBITOL (UNII: 506T60A25R)
ICODEXTRIN (UNII: 2NX48Z0A9G)
ACACIA (UNII: 5C5403N26O)
CALCIUM CARBONATE (UNII: H0G9379FGK)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
CARNAUBA WAX (UNII: R12CBM0EIZ)
WHITE WAX (UNII: 7G1J5DA97F)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
STARCH, CORN (UNII: O8232NY3SJ)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CORN SYRUP (UNII: 9G5L16BK6N)
SHELLAC (UNII: 46N107B71O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SUCROSE (UNII: C151H8M554)
CARMINIC ACID (UNII: CID8Z8N95N)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Product Characteristics
Color	purple	Score	no score
Shape	ROUND	Size	18mm
Flavor	BERRY, MINT	Imprint Code	PB
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-321-70	70 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	12/02/2024

Labeler - The Procter & Gamble Manufacturing Company (004238200)