TOPCARE STOMACH RELIEF CHERRY - bismuth subsalicylate liquid 
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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Topcare Stomach Relief Cherry Liquid

ACTIVE INGREDIENT(in each 30 mL)

Bismuth subsalicylate 525 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 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

benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum

PRINCIPAL DISPLAY PANEL

TOPCARE

COMPARE TO PEPTO-BISMOL® REGULAR STRENGTH ACTIVE INGREDIENT*
NDC 36800-769-04


REGULAR STRENGTH 
Stomach Relief 
BISMUTH SUBSALICYLATE 525 mg per 30 mL
UPSET STOMACH RELIEVER/ANTI-DIARRHEAL

 

5 SYMPTOM DIGESTIVE RELIEF



Cherry Flavor
8 FL OZ (236 mL)


111


TOPCARE STOMACH RELIEF CHERRY 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-769
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-769-06473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/17/2021
2NDC:36800-769-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product12/17/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33512/17/2021
Labeler - Topco Associates, LLC (006935977)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(36800-769)

Revised: 11/2022
Document Id: 42300688-f027-4a64-9317-d2bf8645133a
Set id: 154b4b8f-c4d6-414b-aac3-88475669e19d
Version: 2
Effective Time: 20221121
 
Topco Associates, LLC