Peptic Relief by Rugby Laboratories / Guardian Drug Company PEPTIC RELIEF tablet

Peptic Relief by

Drug Labeling and Warnings

Peptic Relief by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Bismuth Subsalicytate 262mg

Purpose

Upset stomach reliever / anti-diarrheal

KEEP OUT OF REACH OF CHILDREN

Uses

relieves:

• diarrhea
• hearbrun
• indigesttion
• 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

• 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

• chew or dissolve in mouth
• adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
• do not take more than 8 doses (16 tablets) 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 tablet contains: salicylate 102mg
• sodium less than 1 mg 
• very low sodium
• avoid excessive heat (over 104ºF or 40ºC) 

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

INGREDIENTS AND APPEARANCE

PEPTIC RELIEF 
peptic relief tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1021
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	PINK	Score	no score
Shape	ROUND	Size	18mm
Flavor		Imprint Code	GDC;122
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1021-07	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part335	02/20/2014

Labeler - Rugby Laboratories (079246066)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	manufacture(0536-1021)