PEPTO BISMOL ULTRA- bismuth subsalicylate suspension

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 15 mL dose)

Bismuth subsalicylate 525 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

• shake well before use
• only use dose cup provided
• adults and children 12 years and over:
• 15 mL (1 dose) every ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
• 15 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
• do not exceed 8 doses (120 mL) 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 15 mL dose cup contains: magnesium 3 mg, sodium 2 mg
  • salicylate 230 mg
  • low sodium
  • protect from freezing
  • avoid excessive heat (over 104°F or 40°C)
• TAMPER EVIDENT: Do not use if printed shrinkband is missing or broken.

Inactive ingredients

benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, gellan gum, magnesium aluminum silicate, methylcellulose, salicylic acid, sodium salicylate, sorbic acid, sucralose, water

Questions?

1-800-717-3786

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

Pepto

Bismol®ULTRA

Bismuth Subsalicylate
Upset Stomach Reliever/ Antidiarrheal

COATS & COOLS

WITH

INSTACOOL

5 SYMPTOM

RELIEF

NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA

12 FL OZ (354 mL)

INGREDIENTS AND APPEARANCE

PEPTO BISMOL  ULTRA
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-966
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	525 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
WATER (UNII: 059QF0KO0R)
METHYLCELLULOSE (1500 MPA.S) (UNII: P0NTE48364)
GELLAN GUM (HIGH ACYL) (UNII: W1L7G7ROMD)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-966-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/07/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	03/07/2022

Labeler - The Procter & Gamble Manufacturing Company (004238200)