PEPTO-BISMOL- bismuth subsalicylate tablet 
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.

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Pepto•

BISMOL™

Drug Facts

Active ingredient (in each caplet)

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, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate

Questions?

1-800-717-3786

www.pepto-bismol.com

Made in Mexico by Procter & Gamble

Dist. by Procter & Gamble, Cincinnati OH 45202. U.S.

PRINCIPAL DISPLAY PANEL - 24 Caplet Carton

P epto
Bismol
®


Bismuth Subsalicylate

Upset Stomach Reliever/

Antidiarrheal


5 SYMPTOM

RELIEF

NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA

24 CAPLETS

476

PEPTO-BISMOL 
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-476
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE (UNII: FZ989GH94E)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorpinkScoreno score
ShapeOVAL (Caplet) Size16mm
FlavorImprint Code PeptoBismol
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-476-011 in 1 POUCH06/30/2004
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:37000-476-021 in 1 CARTON06/30/2004
224 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:37000-476-031 in 1 CARTON06/30/2004
340 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:37000-476-1217852 in 1 BAG; Type 0: Not a Combination Product06/30/2004
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33506/30/2004
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 3/2018
Document Id: 66d8ffb4-fc98-aab5-e053-2a91aa0a7865
Set id: f047ea34-cad8-4370-94b9-89e8e9ec48c8
Version: 4
Effective Time: 20180307
 
The Procter & Gamble Manufacturing Company