BISMUTH TABS- bismuth subsalicylate tablet, chewable 
DOLGENCORP, LLC

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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Rexall 44-319 Delisted

Active ingredients

Bismuth subsalicylate 262 mg 

Purpose

Upset stomach reliever/Antidiarrheal 

Uses

relieves:

  • heartburn
  • indigestion
  • upset stomach
  • nausea
  • diarrhea 

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 of the blood)
  • diabetes
  • gout
  • arthritis 

When using this product

a temporary, but harmless, darkening of the stool and/or tongue my occur. 

Stop use and ask a doctor if

  • symptoms get worse
  • 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 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
  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • avoid excessive heat
  • store in a dry place
  • see end flap for expiration date and lot number 

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, sodium saccharin, stearic acid, talc 

Principal Display Panel

Since 1903

Rexall®

Bismuth Tabs

Bismuth subsalicylate 262 mg

• Relieves indigestion

• Upset stomach

• Diarrhea

• Heartburn

• Nausea

30 

Chewable Tablets

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

MANUFACTURED FOR DOLGENCORP, LLC

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 USA

GDRX 319 

BISMUTH TABS 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-756
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)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize16mm
FlavorCHERRYImprint Code 44;319
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-756-011 in 1 CARTON
130 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33507/16/199806/26/2016
Labeler - DOLGENCORP, LLC (068331990)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(55910-756)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(55910-756)

Revised: 3/2016
 
DOLGENCORP, LLC