Your browser does not support JavaScript! PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [LIL' DRUG STORE PRODUCTS, INC.]
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RxNorm Names

PEPTO-BISMOL (bismuth subsalicylate) tablet, chewable
[Lil' Drug Store Products, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

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 every 1/2 to 1 hour as needed
  • 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
  • sodium less than 1 mg
  • salicylate 102 mg
  • very low sodium
  • sugar free
  • avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

calcium carbonate, flavor, magnesium stearate, mannitol, povidone, red 27 aluminum lake, saccharin sodium, talc

Questions?

1-800-717-3786

Repackaged and distributed with
permission of manufacturer by:

Lil' Drug Store Products
1201 Continental Place NE
Cedar Rapids, IA 52402

PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton

Pepto
BISMOL™

BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5 SYMPTOM RELIEF

Nausea • Heartburn • Indigestion
Upset Stomach • Diarrhea

4 CHEWABLE
TABLETS

Lil'
DrugStore®

Principal Display Panel - 4 Tablet Pouch Carton
PEPTO-BISMOL 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:66715-9723(NDC:37000-477)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bismuth subsalicylate (Bismuth cation) Bismuth subsalicylate262 mg
Inactive Ingredients
Ingredient NameStrength
calcium carbonate 
magnesium stearate 
mannitol 
povidones 
D&C red no. 27 
aluminum oxide 
saccharin sodium 
talc 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize16mm
FlavorImprint Code Pepto;Bismol
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-9723-22 in 1 CARTON
12 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33509/16/2010
Labeler - Lil' Drug Store Products, Inc. (093103646)
Establishment
NameAddressID/FEIBusiness Operations
CCB Packaging Inc.362374464REPACK(66715-9723), RELABEL(66715-9723)
Establishment
NameAddressID/FEIBusiness Operations
The Proctor & Gamble Manufacturing Company007130032MANUFACTURE(66715-9723)

Revised: 1/2013
 
Lil' Drug Store Products, Inc.

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