GUARDIAN PINK BISMUTH - bismuth subsalicylate tablet, chewable 
Guardian Drug Company

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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Guardian Pink-Bismuth

ACTIVE INGREDIENT(in each tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)


PURPOSE

Upset stomach reliever and anti-diarrheal

USE(S)

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

ASK A DOCTOR BEFORE USE IF YOU HAVE

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

taking any drug for 


WHEN USING THIS PRODUCT

a temporary, but harmless darkening of the stool and/or tongue may occur

STOP USE AND ASK DOCTOR IF

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

PRINCIPAL DISPLAY PANEL

NDC 53041-021-41
*Compare to the active ingredient of Pepto-Bismol® 
Pink-Bismuth Tablets

Original Flavor
Bismuth Subsalicylate 
Anti-diarrheal / Upset Stomach Reliever 

Soothing Relief for:



30 Chewable Tablets



99
GUARDIAN PINK BISMUTH 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-021
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) 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
ShapeROUNDSize16mm
FlavorImprint Code G122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53041-021-415 in 1 BOX10/08/2021
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 FINALpart33510/08/2021
Labeler - Guardian Drug Company (119210276)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(53041-021)

Revised: 11/2022
Document Id: eae72b44-5c9d-4bd8-8aec-ba70651928d0
Set id: 7e83fdf2-4007-46a8-ae9d-eab5a8ff1915
Version: 2
Effective Time: 20221121
 
Guardian Drug Company