REGULAR STRENGTH STOMACH RELIEF- bismuth subsalicylate 525 mg liquid

Regular Strength Stomach Relief by

Drug Labeling and Warnings

Regular Strength Stomach Relief by is a Otc medication manufactured, distributed, or labeled by Retail Business Services, LLC., Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(in each 30 mL)

Bismuth subsalicylate 525 mg

PURPOSE

Upset stomach reliever and anti-diarrheal

USE(S)

relieves:

• diarrhea
• heartburn
• indigestion
• nausea
• upset stomach associated with these symptoms

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

• allergic to salicylates (including aspirin)
• taking other salicylate products

DO NOT USE IF YOU HAVE

• an ulcer
• bloody or black stool
• 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 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

• shake well before use
• mL = milliliter
• TBSP = tablespoon
• adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every 1/2 to 1 hour as needed
• do not exceed 8 doses (16 TBSP or 240 mL) in 24 hours
• use until diarrhea stops but not more than 2 days
• children under 12 years: ask a doctor
• drink plenty of clear fluids to help prevent dehydration caused by diarrhea

OTHER INFORMATION

• each 30 mL or 2 TBSP contains:
• potassium 25 mg
• salicylate 260 mg
• sodium 8 mg
• protect from freezing.
• avoid excessive heat (over 104oF or 40oC).
• dosage cup provided

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

NDC: 72476-527-06
compare to active ingredient in Pepto-Bismol®*

REGULAR STRENGTH STOMACH RELIEF

Bismuth Subsalicylate 525 mg
Upset Stomach Reliever/Anti-Diarrheal

Original Flavor

SOOTHING RELIEF FOR:

UPSET STOMACH, INDIGESTION,

NAUSEA, HEARTBURN, DIARRHEA

PROTECTIVE COATING

NET 16  FL OZ (1 PT) 473 mL

  

INGREDIENTS AND APPEARANCE

REGULAR STRENGTH STOMACH RELIEF 
bismuth subsalicylate 525 mg liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72476-527
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	525 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	PINK	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72476-527-06	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	07/21/2025

Labeler - Retail Business Services, LLC. (967989935)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(72476-527)