STOMACH RELIEF- bismuth subsalicylate tablet, chewable

Stomach Relief by

Drug Labeling and Warnings

Stomach Relief by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC., Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purposes

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

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

PREGNANCY OR BREAST FEEDING

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 77 mg, salicylate 102 mg
• store at 15°-30°C (59°-86°F)
• protect from moisture

Inactive ingredients

calcium carbonate, D&C red # 27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions or comments

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Stomach Relief

30 Tablets   15 Pouches (2 Tablets per Pouch)

NDC: 69842-394-54

INGREDIENTS AND APPEARANCE

STOMACH RELIEF 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-394
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTROSE (UNII: IY9XDZ35W2)
CHERRY (UNII: BUC5I9595W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	PINK (light)	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY	Imprint Code	AP;045
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-394-54	15 in 1 CARTON	11/28/2017
1		2 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	11/28/2017

Labeler - CVS PHARMACY, INC. (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Advance Pharmaceutical Inc.		078301063	MANUFACTURE(69842-394)