PEPTO BISMOL CHEWABLE 5 SYMPTOMS RELIEF- bismuth subsalicylate tablet, chewable

Pepto Bismol Chewable 5 Symptoms Relief by

Drug Labeling and Warnings

Pepto Bismol Chewable 5 Symptoms Relief by is a Otc medication manufactured, distributed, or labeled by JC World Bell Wholesale Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each 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 (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea
2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
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  low sodium
avoid excessive heat (over 104°F or 40°C)

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:50269-555-01

Package Labeling:50269-555-02

INGREDIENTS AND APPEARANCE

PEPTO BISMOL CHEWABLE 5 SYMPTOMS RELIEF 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50269-555(NDC:58933-011)
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 ALUMINUM LAKE (UNII: ZK64F7XSTX)
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: 50269-555-01	6 in 1 BOX	06/30/2004
1		1 in 1 BLISTER PACK
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 50269-555-02	6 in 1 BOX	06/30/2004
2		1 in 1 BLISTER PACK
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 Drug	M008	06/30/2004

Labeler - JC World Bell Wholesale Co., Inc. (805257581)

Registrant - JC World Bell Wholesale Co., Inc. (805257581)