CHEWABLE STOMACH RELIEF- bismuth subsalicylate tablet, chewable

Chewable Stomach Relief by

Drug Labeling and Warnings

Chewable Stomach Relief by is a Otc medication manufactured, distributed, or labeled by PUBLIX SUPER MARKETS INC,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable tablet)

Bismuth subsalicylate 262 mg

Purpose

Antidiarrheal/ upset stomach reliever

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 or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

Do not use if you are

• ▪ allergic to salicylate (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 of 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 breastfeeding, 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 immediately at 1-800-222-1222

Directions

• ▪ chew or dissolve tablets 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
• ▪ drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• ▪ children under 12 years: ask a doctor

Other information

• ▪ each tablet contains: salicylate 102 mg
• ▪ Store at room temperature
• ▪ avoid excessive heat
• ▪ keep this carton for future reference on full labeling

Inactive ingredients

flavor, magnesium stearate, microcrystalline cellulose, red #27 aluminum lake, sorbitol, sucralose.

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

Compare to active ingredient in Pepto-Bismol® Chewable Tablets*

Pink bismuth chewable tablets

Original flavor

bismuth subsalicylate 262mg/antidiarrheal

upset stomach, indigestion ,nausea, heartburn, diarrhea

30 CHEWABLE TABLETS

DO NOT USE IF INDIVIDUAL BLISTER COMPARTMENTS ARE TORN OR OPEN

*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

Publix.com

INGREDIENTS AND APPEARANCE

CHEWABLE STOMACH RELIEF 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41415-124
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
magnesium stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
D&C RED NO. 27 (UNII: 2LRS185U6K)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PINK (light-pink)	Score	no score
Shape	ROUND	Size	16mm
Flavor	WINTERGREEN	Imprint Code	RP124
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41415-124-30	5 in 1 CARTON	06/30/2017
1		6 in 1 BLISTER PACK; 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	06/30/2017

Labeler - PUBLIX SUPER MARKETS INC, (006922009)