STOMACH RELIEF ULTRA- bismuth subsalicylate liquid 
Rugby Laboratories, Inc.

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Drug Facts

Active ingredient (in each 15 mL)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever/Antidiarrheal

Uses

relieves

Warnings

 Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms ahould 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

  • an ulcer
  • a bleeding problem
  • bloody or black stool

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

  • diabetes
  • gout
  • arthritis
  • anticoagulation (thinning the blood)

When using this product

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

Stop use and ask a doctor if

  • symptoms get worse or last more than 2 days
  • 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 childen.

In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away.

Directions


Other information

Inactive ingredients

benzoic acid, D&C red #22, D&C red #28, flavor, glycerin, purified water, sucralose, xanthan gum

Questions or comments?

Call 1-800-645-2158

Principal Display Panel

Compare to the active ingredient in Pepto-Bismol® Ultra*

Extra Strength

Stomach Relief

Bismuth Subsalicylate 525 mg

Upset Stomach Reliever/Antidiarrheal

Relieves:

2x Strength Per Ounce†

Alcohol Free • Sugar Free

FL OZ (mL)

*This product is not manufactured or distributed by The Procter & Gamble Company. Pepto-Bismol® is a registered trademark of The Procter & Gamble Company.

†vs Original Pepto-Bismol®

TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING

Distributed by:

RUGBY® LABORATORIES

17177 N Laurel Park Drive

Suite 233, Livonia, MI 48152

www.rugbylaboratories.com

Package Label

Bismuth Subsalicylate 525 mg

RUGBY Extra Strength Stomach Relief

STOMACH RELIEF  ULTRA
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1287
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 15 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1287-36237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00803/29/2020
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 4/2024
Document Id: 644a4d17-5c52-4892-8075-fe8f791a3cf6
Set id: 87394088-1d2e-4ca4-bbfe-1481c9d4a3ba
Version: 3
Effective Time: 20240422
 
Rugby Laboratories, Inc.