CHEWABLE- bismuth subsalicylate tablet, chewable

chewable by

Drug Labeling and Warnings

chewable by is a Otc medication manufactured, distributed, or labeled by Publix Super Markets Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever/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
• kidney stones
• a calcium-restricted diet

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
• 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. (1-800-222-1222)

Directions

• chew or dissolve tablets in mouth
• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• adults and children 12 years and over: 2 tablets every ½ to 1 hour, or 4 tablets every hour as needed
• do not exceed 16 tablets in 24 hours
• use until diarrhea stops but not more than 2 days
• children under 12 years: ask a doctor

Other information

• each tablet contains: calcium 265 mg and salicylate 99 mg
• store at 20°-25°C (68°-77°F)

Inactive ingredients

calcium carbonate, D&C red #27 aluminum lake, FD&C blue #1 aluminum lake, flavor, magnesium stearate, mannitol, saccharin sodium

Principal Display Panel

STOMACH RELIEF

chewable

BISMUTH SUBSALICYLATE 262mg

ANTIDIARRHEAL

UPSET STOMACH RELIEVER

Soothing relief for:

heartburn

indigestion

upset stomach

nausea

diarrhea

ACTUAL SIZE

Compare to Active Ingredient in Pepto-Bismol® Chewable Tablets

Chewable Carton Image 1

Chewable Carton Image 2

INGREDIENTS AND APPEARANCE

CHEWABLE 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56062-469
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	17mm
Flavor		Imprint Code	L469
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56062-469-65	5 in 1 CARTON
1		6 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	03/15/2001

Labeler - Publix Super Markets Inc (006922009)