STOMACH RELIEF- bismuth subsalicylate tablet

Stomach Relief by

Drug Labeling and Warnings

Stomach Relief by is a Otc medication manufactured, distributed, or labeled by CDMA- QC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Bismuth subsalicylate 262mg (each tablet contains 102mg salicylate)

Purpose

Antidiarrheal/Antacid

Use(s)

• 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

• an ulcer
• a bleeding problem
• bloody or black stool
  

Ask a doctor before use if

• 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
• ringing in the ears or loss of hearing occurs
• diarrhea lasts more than 2 days
  

Pregnancy/Breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

In case of accidental overdose, get medical help or contact a Poison Control Center
(1-800-222-1222) right away.

Directions

Chew or dissolve in mouth

Adults and children 12 years and over:

• 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every
  hour as needed for diarrhea 
• 2 tablets (1 dose) every ½ 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 of age: ask a doctor

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

Phenylketonurics: contains phenylalanine 1.1mg per tablet Calcium content per tablet: 73mg

Do not use if cellophane unit is torn

Storage

Store at room temperature 15°– 30°C (59°– 86°F)

Inactive ingredients

acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum
lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

Principal Display Panel

Stomach Relief

INGREDIENTS AND APPEARANCE

STOMACH RELIEF 
bismuth subsalicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-622
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
ASPARTAME (UNII: Z0H242BBR1)
ACACIA (UNII: 5C5403N26O)
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTRATES (UNII: G263MI44RU)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PEPPERMINT (UNII: V95R5KMY2B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	17mm
Flavor		Imprint Code	RH046
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-622-30	30 in 1 CELLO PACK; Type 0: Not a Combination Product	06/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	12/23/2014

Labeler - CDMA- QC (011920774)