PEPTO-BISMOL- bismuth subsalicylate tablet 
Select Corporation

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.

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Pepto-Bismol Chewable Tablets

Drug Facts

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and Antidiarrheal

Uses

relieves

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

Other information

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:
Select Corporation Carrollton, TX 75007

PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Blister Pack

Pepto-
Bismol

BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5
SYMPTOM
Digestive Relief

4 Chewable Tablets
Multi-Pack

PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Blister Pack
PEPTO-BISMOL 
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-903(NDC:37000-477)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bismuth subsalicylate (UNII: 62TEY51RR1) (salicylic acid - UNII:O414PZ4LPZ) bismuth subsalicylate262 mg
Inactive Ingredients
Ingredient NameStrength
calcium carbonate (UNII: H0G9379FGK)  
magnesium stearate (UNII: 70097M6I30)  
mannitol (UNII: 3OWL53L36A)  
povidone, unspecified (UNII: FZ989GH94E)  
D&C red no. 27 aluminum lake (UNII: ZK64F7XSTX)  
saccharin sodium (UNII: SB8ZUX40TY)  
talc (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize16mm
FlavorWINTERGREENImprint Code Pepto;Bismol
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52904-903-041 in 1 BLISTER PACK06/30/2004
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:52904-903-052 in 1 BLISTER PACK06/30/2004
22 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33506/30/2004
Labeler - Select Corporation (053805599)

Revised: 4/2022
Document Id: 25d8dc24-31e7-48f3-97c5-31cc02bdd787
Set id: 0b3a5a1a-2c1b-48ce-a3fe-bbcda23631f3
Version: 1
Effective Time: 20220415
 
Select Corporation