Your browser does not support JavaScript! PEPTO-BISMOL (BISMUTH SUBSALICYLATE) LIQUID [PROCTER & GAMBLE MANUFACTURING COMPANY]
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PEPTO-BISMOL (bismuth subsalicylate) liquid
[Procter & Gamble Manufacturing Company]


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 15 ml Tablespoon)

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

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

  • diarrhea lasts more than 2 days
  • symptoms get worse or last more than 2 days
  • ringing in the ears or loss of hearing occurs

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

  • shake well before use
  • for accurate dosing, use dose cup
  • adults and children 12 years and over:
    1 dose (2 Tbsp or 30 ml) every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 Tbsp or 240 ml) 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 Tbsp contains: sodium 6 mg
  • salicylate 118 mg
  • protect from freezing
  • sugar free
  • avoid excessive heat (over 104°F or 40°C)
  • low sodium
  • TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken.

Inactive ingredients

benzoic acid, flavor, magnesium aluminum silicate, methylcellulose, red 22, red 28, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, sucralose, water

Questions?

1-800-717-3786

Dist. by Procter & Gamble,
Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

NDC 37000-475-08

Pepto-
BISMOL™

BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER / ANTIDIARRHEAL

5 SYMPTOM RELIEF
Nausea ∙ Heartburn ∙ Indigestion
Upset Stomach ∙ Diarrhea

CHERRY

8 FL OZ (236 mL)

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
PEPTO-BISMOL 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37000-475
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bismuth subsalicylate (Salicylic acid and Bismuth cation) Bismuth subsalicylate525 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
benzoic acid 
magnesium aluminum silicate 
D&C red no. 22 
D&C red no. 28 
saccharin sodium 
salicylic acid 
sodium salicylate 
sorbic acid 
sucralose 
water 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-475-04118 mL in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
2NDC:37000-475-08236 mL in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
3NDC:37000-475-12354 mL in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
4NDC:37000-475-16473 mL in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33506/30/2004
Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 9/2014
 
Procter & Gamble Manufacturing Company

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