Pepto-Bismol Cherry: Package Insert and Label Information

PEPTO-BISMOL CHERRY- bismuth subsalicylate suspension
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each 30 mL dose)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and antidiarrheal

Uses

relieves

  • traveler’s 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:
  • 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea
  • 30mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (240 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 30 mL dose contains: magnesium 4 mg, sodium 3 mg
    • salicylate 236 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

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL — 354 mL Bottle Label

P e pto

Bismol ®

Bismuth Subsalicylate
Upset Stomach Reliever/
Antidiarrheal

CHERRY
5 SYMPTOM

RELIEF

NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA

12 FL OZ (354 mL)

439
(click image for full-size original)
PEPTO-BISMOL CHERRY
bismuth subsalicylate suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-439
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISMUTH SUBSALICYLATE (SALICYLIC ACID and BISMUTH CATION) BISMUTH SUBSALICYLATE 525 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID
MAGNESIUM ALUMINUM SILICATE
D&C RED NO. 22
D&C RED NO. 28
SUCRALOSE
SALICYLIC ACID
SODIUM SALICYLATE
SORBIC ACID
WATER
METHYLCELLULOSE (1500 MPA.S)
GELLAN GUM (HIGH ACYL)
Product Characteristics
Color pink Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37000-439-08 236 mL in 1 BOTTLE, PLASTIC None
2 NDC:37000-439-12 354 mL in 1 BOTTLE, PLASTIC None
3 NDC:37000-439-16 473 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part335 03/01/2018
Labeler — The Procter & Gamble Manufacturing Company (004238200)

Revised: 05/2020 The Procter & Gamble Manufacturing Company

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