STOMACH RELIEF- bismuth subsalicylate tablet 
Strategic Sourcing Services LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sunmark Stomach relief

Active ingredient (in each caplet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and anti-diarrheal

Uses

relieves:

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

Do not use if you have

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

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
  • 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 immediately.

Directions

Other information

Inactive ingredients

calcium carbonate, colloidal silicon dioxide, D&C red 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate.

Principal Display Panel

sunmark

COMPARE TO PEPTO-BISMOL® ACTIVE INGREDIENT

NDC # 49348-511-59

stomach relief

Soothing relief for upset stomach, indigestion, nausea, heartburn and diarrhea

ORIGINAL FORMULA

40 CAPLETS

image description

STOMACH RELIEF 
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-511
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorpinkScoreno score
ShapecapsuleSize16mm
FlavorImprint Code G172
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-511-591 in 1 CARTON09/27/2019
140 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33509/27/2019
Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 1/2022
Document Id: 66109236-d86e-4fd3-937d-8067fa43a34c
Set id: e0439ad7-ce90-407f-ae50-1ec1bb11d715
Version: 4
Effective Time: 20220106
 
Strategic Sourcing Services LLC