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Pepto Relief by Richmond Pharmaceuticals, Inc

Medically reviewed on October 30, 2017

Dosage form: tablet, chewable
Ingredients: BISMUTH SUBSALICYLATE 262mg
Labeler: Richmond Pharmaceuticals, Inc
NDC Code: 54738-102

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.

PEPTO RELIEF Bismuth Subsalicylate 262 MG

Drug Facts

.

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 INGREDIENT

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

Questions or Comments

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

Call 804-270-4498, 8.30 am – 4.30 pm EST Monday - Friday

Package Label

NDC:  54738-102-30

– 30 TABLETS

NDC: 54738-102-48- 48  TABLETS

PEPTO RELIEF 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54738-102
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (BISMUTH CATION) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
D&C RED NO. 27 
DEXTROSE 
CHERRY 
MAGNESIUM STEARATE 
MALTODEXTRIN 
SILICON DIOXIDE 
SORBITOL 
Product Characteristics
Colorpink (light) Scoreno score
ShapeROUNDSize16mm
FlavorCHERRYImprint CodeAP;045
Contains    
Packaging
#Item CodePackage Description
1NDC:54738-102-3030 TABLET, CHEWABLE in 1 BOTTLE
2NDC:54738-102-4848 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33506/01/2015
Labeler - Richmond Pharmaceuticals, Inc (043569607)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063manufacture(54738-102)

 
Richmond Pharmaceuticals, Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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