PEPTO BISMOL- bismuth subsalicylate tablet, chewable

Pepto Bismol by

Drug Labeling and Warnings

Pepto Bismol by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each Chewable tablet)

Bismuth subsalicylate 262 mg

Purpose

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  fullness

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

 chew or dissolve in mouth
 adults and children 12 years and over:

 2 tablets every 1/2 to 1 hour as needed
 do not exceed 8 doses (16 tablets) 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 tablet contains:

 calcium 140 mg

magnesium 9 mg
 salicylate 101 mg
 very low sodium
 protect from freezing
 avoid excessive heat (over 104°F or 40°C)

do not use if pouch is opened

Inactive ingredients

calcium carbonate, D&C red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

Questions?

1-800-717-3786

Package Labeling:

INGREDIENTS AND APPEARANCE

PEPTO BISMOL 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-155(NDC:37000-477)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE (UNII: FZ989GH94E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	16mm
Flavor	WINTERGREEN	Imprint Code	Pepto;Bismol
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-155-01	1 in 1 CARTON	09/20/2016
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 67751-155-02	1 in 1 CARTON	09/20/2016
2		4 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	09/20/2016

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	repack(67751-155) , relabel(67751-155)