PEPTIC RELIEF- peptic relief tablet 
Rugby Laboratories

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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Peptic Relief 

Active ingredient (in each tablet)

Bismuth Subsalicytate 262mg

Purpose

Upset stomach reliever / 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

  • if you have bloody or black stool
  • an ulcer
  • 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 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 a 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

Other information

Inactive ingredients

calcium carbonate, D&C red #27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium

Questions or comments?

1-800-645-2158

PDP

COMPARE TO THE ACTIVE INGREDINET IN PEPTO-BISMOL®*

Rugby®

NDC 0536-1021-07

Peptic Relief

Bismuth Subsalicylate 262 mg

FOR UPSET STOMACH, INDIGESTION, SIMPLE DIARRHEA AND NAUSEA

30 CHEWABLE TABLETS

image description

PEPTIC RELIEF 
peptic relief tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1021
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 (UNII: 2LRS185U6K)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
STARCH, CORN (UNII: O8232NY3SJ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize18mm
FlavorImprint Code GDC;122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1021-0730 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33502/20/2014
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276manufacture(0536-1021)

Revised: 1/2022
Document Id: 429ee2d1-2c5c-4967-bf7d-0e1e8ebd2768
Set id: 713a580e-9ddb-44cd-8989-7411b7fd647c
Version: 5
Effective Time: 20220111
 
Rugby Laboratories