PEPTO-BISMOL- bismuth subsalicylate tablet 
Procter & Gamble Manufactura S de RL de CV

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Pepto BISMOL ® Caplets

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

• swallow with water, do not chew
• adults and children 12 years and over:

• do not exceed 8 doses (16 caplets) 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

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

TAMPER EVIDENT: Do not use if inner printed seal on bottle is broken or missing.

Made in Mexico

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 24 Caplet Carton

Pepto
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:58933-476
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
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorpinkScoreno score
ShapeOVAL (Caplet) Size16mm
FlavorImprint Code PeptoBismol
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58933-476-011 in 1 POUCH06/30/2004
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:58933-476-021 in 1 CARTON06/30/2004
224 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58933-476-031 in 1 CARTON06/30/2004
340 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:58933-476-1217852 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 DrugM00806/30/2004
Labeler - Procter & Gamble Manufactura S de RL de CV (812807550)

Revised: 10/2023
Document Id: 070d0fc2-c07e-5f13-e063-6294a90a877d
Set id: 66d9d631-ba73-3ce4-e053-2a91aa0a1cc4
Version: 7
Effective Time: 20231006
 
Procter & Gamble Manufactura S de RL de CV