SUNMARK STOMACH RELIEF- bismuth subsalicylate tablet, chewable 
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 tablets Regular Strength

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

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 stools
  • 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

each tablet contains:

Inactive ingredients

calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.

Principal Display Panel

sunmark

COMPARE TO PEPTO-BISMOL® CHEWABLE TABLETS ACTIVE INGREDIENT*

NDC 49348-953-44

stomach relief tablets

Regular Strength

Antidiarrheal/Upset Stomach Reliever

Soothing relief for upset stomach, nausea

heartburn, indigestion and diarrhea

BISMUTH SUBSALICYLATE 262 mg

CHEWABLE

30 TABLETS

image description

SUNMARK STOMACH RELIEF 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-953
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)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
STARCH, CORN (UNII: O8232NY3SJ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize17mm
FlavorImprint Code GDC122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-953-445 in 1 CARTON09/24/2019
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33509/24/2019
Labeler - Strategic Sourcing Services LLC (116956644)
Registrant - Guardian Drug Company (119210276)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276manufacture(49348-953)

Revised: 1/2022
Document Id: a8dc8bda-40d3-456c-853f-d972b920741e
Set id: 0dd0efab-911d-48c4-8236-a0be35c19d96
Version: 6
Effective Time: 20220107
 
Strategic Sourcing Services LLC