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Stomach Relief by Harmon Store Inc.

Medically reviewed on July 17, 2017

Dosage form: tablet, chewable
Ingredients: BISMUTH SUBSALICYLATE 262mg
Labeler: Harmon Store Inc.
NDC Code: 63940-319

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.

Core Values 44-319

Active ingredients (in each tablet)

Bismuth subsalicylate 262 mg 

Purpose

Upset stomach reliever/antidiarrheal 

Uses

relieves:

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

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 of 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 (1-800-222-1222) right away. 

Directions
  • chew or dissolve in mouth
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • 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 

Other information
  • each tablet contains: calcium 40 mg, salicylate 102 mg
  • TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF CELLOPHANE UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
  • see end flap for expiration date and lot number
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat
  • store in a dry place

Inactive ingredients

calcium carbonate, cherry flavor, D&C red #27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, mannitol, povidone, saccharin sodium, stearic acid, talc 

Principal Display Panel

CORE✓ALUES™

NDC 63940-319-01

Compare to active ingredient in Pepto-Bismol®†

Stomach Relief
Bismuth subsalicylate 262 mg
Upset Stomach Reliever/
Antidiarrheal

Relieves:
• Nausea,
• Heartburn
• Indigestion
• Upset Stomach
• Diarrhea

Actual Size

30 chewable tablets           cherry flavor

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF CELLOPHANE UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed by: Liberty Procurement, Inc.,
650 Liberty Ave., Union, NJ 07083 U.S.A
Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Pepto-Bismol®.
50844    ORG021531901

Core Values 44-319

STOMACH RELIEF 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-319
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
D&C RED NO. 27 
D&C RED NO. 30 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
MANNITOL 
POVIDONE 
SACCHARIN SODIUM 
STEARIC ACID 
TALC 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize16mm
FlavorCHERRYImprint Code44;319
Contains    
Packaging
#Item CodePackage Description
1NDC:63940-319-015 POUCH in 1 CARTON
16 TABLET, CHEWABLE in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33507/16/1998
Labeler - Harmon Store Inc. (804085293)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63940-319)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(63940-319)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(63940-319)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(63940-319)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(63940-319)

 
Harmon Store Inc.

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Further information

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

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