TOPCO STOMACH RELIEF - bismuth subsalicylate tablet 
Topco Associates, 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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Topco Stomach Relief Caplets

ACTIVE INGREDIENT(in each caplet)

Bismuth subsalicylate 262 mg



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 behaviour 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 right away.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

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

PRINCIPAL DISPLAY PANEL

Topcare health

COMPATE TO PEPTO-BISMOL®  ACTIVE INGREDIENT*

NDC 36800-104-28

Stomach Relief
BISMUTH SUBSALICYLATE 262 mg
UPSET STOMACH RELIEVER / ANTIDIARRHEAL

5 SYMPTOM RELIEF 


40 CAPLETS

64


TOPCO STOMACH RELIEF 
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-104
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code G;172
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-104-281 in 1 CARTON10/01/2020
140 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33510/01/2020
Labeler - Topco Associates, LLC (006935977)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(36800-104)

Revised: 11/2022
Document Id: 4c1cf5e1-495e-4a59-a626-4c39e7dee0f7
Set id: 7a5be682-f13b-41a4-bf8c-724bffab2e92
Version: 2
Effective Time: 20221128
 
Topco Associates, LLC