PEPTO DIARRHEA- bismuth subsalicylate suspension

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)
Available from:
The Procter & Gamble Manufacturing Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antidiarrheal relieves - travelers' diarrhea - diarrhea
Authorization status:
OTC monograph final
Authorization number:
37000-538-04

PEPTO DIARRHEA- bismuth subsalicylate suspension

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® Diarrhea

Drug Facts

Active ingredient (in each 10 mL dose)

Bismuth subsalicylate 525 mg

Purpos e

Antidiarrheal

Us es

relieves

travelers' diarrhea

diarrhea

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

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

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

shake well before use

only use dose cup provided

adults and children 12 years and over:

10 mL (1 dose) every ½ hour or 20 mL (2 doses) every hour as needed for diarrhea/traveler's

diarrhea

do not exceed 8 doses (80 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 10 mL dose contains: salicylate 212 mg

low sodium

store at no greater than 30°C

protect from freezing

avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, gellan gum, magnesium aluminum silicate,

methylcellulose, salicylic acid, sodium salicylate, sorbic acid, sucralose, water

Ques tions ?

1-800-717-3786

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

P epto

Bismol

Diarrhea

CHERRY

4 FL OZ

(118 ml)

CONCENTRATED RELIEF

NEW CONCENTRATED FORMULA: SEE NEW DIRECTIONS

Pepto®

Diarrhea

Bismuth Subsalicylate

Antidiarrheal

CHERRY

RELIEVES

DIARRHEA

4 FL OZ (118 mL)

PEPTO DIARRHEA

bismuth subsalicylate suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:370 0 0 -538

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

The Procter & Gamble Manufacturing Company

BISMUTH SUBSALICYLATE (UNII: 6 2TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ,

BISMUTH CATION - UNII:ZS9 CD1I8 YE)

BISMUTH

SUBSALICYLATE

525 mg

in 30 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

MAGNESIUM ALUMINUM SILICATE (UNII: 6 M3P6 4V0 NC)

D&C RED NO . 2 2 (UNII: 16 78 RKX8 RT)

D&C RED NO . 2 8 (UNII: 76 7IP0 Y5NH)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

SALICYLIC ACID (UNII: O414PZ4LPZ)

SO DIUM SALICYLATE (UNII: WIQ1H8 5SYP)

SO RBIC ACID (UNII: X0 45WJ9 8 9 B)

WATER (UNII: 0 59 QF0 KO0 R)

METHYLCELLULO SE ( 150 0 MPA.S) (UNII: P0 NTE48 36 4)

GELLAN GUM ( HIGH ACYL) (UNII: W1L7G7ROMD)

Product Characteristics

Color

pink

S core

S hap e

S iz e

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:370 0 0 -538 -

118 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 3/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt335

0 3/0 1/20 18

Labeler -

T he Procter & Gamble Manufacturing Company (004238200)

Revised: 3/2019

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