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Stomach Relief by PuraCap Pharmaceutical LLC

Dosage form: tablet, chewable
Ingredients: BISMUTH SUBSALICYLATE 262mg
Labeler: PuraCap Pharmaceutical LLC
NDC Code: 51013-321

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.

Stomach Relief

Drug Facts

Active Ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purposes

Upset stomach reliever and antidiarrheal

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness

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
  • 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
  • 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 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 children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 exceed 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: 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 toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Stomach Relief

30 Tablets   15 Pouches (2 Tablets per Pouch)

NDC: 51013-321-54

STOMACH RELIEF 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-321
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:51013-321-5415 POUCH in 1 CARTON
12 TABLET, CHEWABLE in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33511/28/2017
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063MANUFACTURE(51013-321)

 
PuraCap Pharmaceutical LLC

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Medically reviewed on Nov 28, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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