OTC Medication Information: Pepto-Bismol

PEPTO-BISMOL — bismuth subsalicylate tablet, chewable
PEPTO-BISMOL CHEWABLE, CVP HEALTH- bismuth subsalicylate tablet, chewable
PEPTO-BISMOL CHEWABLE, TRAVEL BASIX — bismuth subsalicylate tablet, chewable
Lil’ Drug Store Products, Inc.

Drug Facts

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purposes

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

  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 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 tablet contains: calcium 140 mg, magnesium 9 mg
  • salicylate 101 mg
  • low sodium
  • avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

calcium carbonate, D&C Red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

Questions?

1-800-717-3786

PRODUCT REPACKAGED AND DISTRIBUTED WITH PERMISSION OF MANUFACTURER BY:
Lil’ Drug Store Products, Inc.,1201 Continental Place NE, Cedar Rapids, IA 52402

Pepto Bismol Chewables, 6ct Lil’ Drug Store — PDP/Package

PRINCIPAL DISPLAY PANEL -- 6 Tablet Cello Pack Carton
(click image for full-size original)
Pepto-Bismol ®

Bismuth Subsalicylate Upset Stomach Reliever/Antidiarrheal

CHEWABLES

5 SYMPTOM

RELIEF NAUSEA,

HEARTBURN, INDIGESTION,

UPSET STOMACH, DIARRHEA

6 Chewable Tablets

[Lil’ Drug Store ® logo]

Pepto Bismol ® Chewables, 4ct TRAVEL BASIX — PDP/Package

Pepto

Bismol ®

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

CHEWABLES

5 SYMPTOM

RELEIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

4

Chewable Tablets

[TRAVEL BASIX logo]

PDP/Package
(click image for full-size original)

Pepto Bismol ® Chewables, 4ct CVP HEALTH — PDP/Package

Pepto

Bismol ®

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

CHEWABLES

5 SYMPTOM

RELEIEF

NAUSEA

HEARTBURN, INDIGESTION

UPSET STOMACH, DIARRHEA

4

Chewable Tablets

[CVP HEALTH logo]

PDP/Package
(click image for full-size original)

PEPTO-BISMOL
bismuth subsalicylate tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9723
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE 262 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 27 ALUMINUM LAKE
MAGNESIUM STEARATE
MANNITOL
POVIDONE, UNSPECIFIED
SACCHARIN SODIUM
TALC
CALCIUM CARBONATE
Product Characteristics
Color pink Score no score
Shape ROUND Size 16mm
Flavor WINTERGREEN Imprint Code Pepto;Bismol
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66715-9723-2 2 POUCH in 1 CARTON contains a POUCH
1 2 TABLET, CHEWABLE in 1 POUCH This package is contained within the CARTON (66715-9723-2)
2 NDC:66715-9723-3 3 POUCH in 1 CARTON contains a POUCH
2 2 TABLET, CHEWABLE in 1 POUCH This package is contained within the CARTON (66715-9723-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M008 09/16/2010
PEPTO-BISMOL CHEWABLE, CVP HEALTH
bismuth subsalicylate tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6523
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE 262 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 27 ALUMINUM LAKE
MAGNESIUM STEARATE
MANNITOL
POVIDONE, UNSPECIFIED
SACCHARIN SODIUM
TALC
CALCIUM CARBONATE
Product Characteristics
Color pink Score no score
Shape ROUND Size 16mm
Flavor WINTERGREEN Imprint Code Pepto;Bismol
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66715-6523-2 2 POUCH in 1 CARTON contains a POUCH
1 2 TABLET, CHEWABLE in 1 POUCH This package is contained within the CARTON (66715-6523-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M008 05/06/2022
PEPTO-BISMOL CHEWABLE, TRAVEL BASIX
bismuth subsalicylate tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6423
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE 262 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 27 ALUMINUM LAKE
MAGNESIUM STEARATE
MANNITOL
POVIDONE, UNSPECIFIED
SACCHARIN SODIUM
TALC
CALCIUM CARBONATE
Product Characteristics
Color pink Score no score
Shape ROUND Size 16mm
Flavor WINTERGREEN Imprint Code Pepto;Bismol
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66715-6423-2 2 POUCH in 1 CARTON contains a POUCH
1 2 TABLET, CHEWABLE in 1 POUCH This package is contained within the CARTON (66715-6423-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M008 11/29/2022
Labeler — Lil’ Drug Store Products, Inc. (093103646)

Revised: 10/2023 Lil’ Drug Store Products, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.