Bismuth subsalicylate by Rugby Laboratories Inc. / Advance Pharmaceutical Inc. Peptic Relief

Bismuth subsalicylate by

Drug Labeling and Warnings

Bismuth subsalicylate by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories Inc., Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BISMUTH SUBSALICYLATE- bismuth subsalicylate tablet 
Rugby Laboratories Inc.

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 subsalicylate 262 mg

Purpose

Anti-diarrheal / Upset stomach reliever

Uses

  • controls diarrhea
  • relieves upset stomach due to overindulgence in food or drink

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: Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
  •   Do not use
  • If you have bloody or black stool
  • If you have an ulcer or 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 right away.

Directions

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • repeat dosage every 1/2 to 1 hour as needed
  • do not take more than 8 doses in 24 hours
  • use until diarrhea stops but not more than 2 days
  • adults and children 12 years and over: 2 tablets
  • children under 12 years: ask a doctor

Other Information

  • Each tablet contains: calcium 77 mg, salicylate 102 mg
  • store at 15°-30°C (59°-86°F)
  • protect from moisture

Inactive Ingredients

calcium carbonate, D&C red # 27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions or Comments

Call 1-800-645-2158, Monday – Friday, 9 am – 5 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

COMPARE TO ACTIVE INGREDIENT IN PEPTO-BISMOL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bottle label

NDC: 0536-4301-07

Rugby

Peptic Relief

Bismuth Subsalicylate 262mg

30 Chewable Tablets

BISMUTH SUBSALICYLATE 
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-4301
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
CHERRY (UNII: BUC5I9595W)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorPINK (light) Scoreno score
ShapeROUNDSize16mm
FlavorCHERRYImprint Code AP;045
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-4301-0730 in 1 BOTTLE; Type 0: Not a Combination Product01/23/199607/29/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33501/23/199607/29/2018
Labeler - Rugby Laboratories Inc. (079246066)

Revised: 12/2019