GNP STOMACH RELIEF - bismuth subsalicylate 525 mg liquid 
Amerisource Bergen

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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GNP Stomach Relief Original Strength-527 

ACTIVE INGREDIENT(in each 30 mL)

Bismuth subsalicylate 525 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

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

GOOD NEIGHBOR PHARMACY®

NDC 46122-703-26

PROTECTIVE COATING ACTION

Stomach Relief

Original Strength
Anti-diarrheal / Upset Stomach Reliever
Bismuth subsalicylate (525mg/30mL)
soothing relief for: indigestion, nausea, heartburn, upset stomach & diarrhea

4 FL. OZ. (118 mL)


527-03
GNP STOMACH RELIEF 
bismuth subsalicylate 525 mg liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-703
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, 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
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-703-26118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33506/30/2022
Labeler - Amerisource Bergen (007914906)

Revised: 6/2022
Document Id: ead13b6b-de37-49f9-b18e-68096651d47e
Set id: ead13b6b-de37-49f9-b18e-68096651d47e
Version: 1
Effective Time: 20220630
 
Amerisource Bergen