REGULAR STRENGTH STOMACH RELIEF- bismuth subsalicylate tablet, chewable 
DOLGENCORP, 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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727R Dollar General 55910-204 Bismuth Subsalicylate tablets 262 mg

Drug Facts

Active ingredient (in each tablet)
Bismuth subsalicylate 262 mg

Purpose
Upset stomach reliever and antidiarrheal

Uses relieves
travelers' diarrhea
diarrhea
upset stomach due to overindulgence in food and drink, including:
o heartburn
o indigestion
o nausea
o gas
o belching
o 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 (1-800-222-1222).

Directions

chew or dissolve in mouth
adults and children 12 years and over:

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

Inactive ingredients calcium carbonate, D&C red #27 lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

Questions or comments?

call 1-877-290-4008

727R-DG-Bismuth-30s-ifc

REGULAR STRENGTH STOMACH RELIEF 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-204
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
Product Characteristics
Colorpink (Light pink to pink) Scoreno score
ShapeROUNDSize15mm
FlavorImprint Code 118
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-204-305 in 1 CARTON09/18/2023
16 in 1 CELLO PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00809/18/2023
Labeler - DOLGENCORP, INC. (068331990)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Marksans Pharma Ltd925822975manufacture(55910-204)

Revised: 9/2023
Document Id: 01d9f722-be63-c8a2-e063-6394a90a87e2
Set id: f2ec112f-213c-8a23-e053-2995a90a5f3f
Version: 2
Effective Time: 20230916
 
DOLGENCORP, INC.