REGULAR STRENGTH STOMACH RELIEF- bismuth subsalicylate tablet, chewable

Regular Strength Stomach Relief by

Drug Labeling and Warnings

Regular Strength Stomach Relief by is a Otc medication manufactured, distributed, or labeled by DOLGENCORP, INC., TIME CAP LABORATORIES, INC., Marksans Pharma Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)
Bismuth subsalicylate 262 mg

PURPOSE

Purpose
Upset stomach reliever and antidiarrheal

INDICATIONS & USAGE

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

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).

DOSAGE & ADMINISTRATION

Directions

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

• 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
• 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

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 SAFETY INFORMATION

Other information

• each tablet contains: calcium 140 mg
• salicylate 101 mg
• low sodium
• avoid excessive heat (over 104°F or 40°C)

INACTIVE INGREDIENT

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

QUESTIONS

Questions or comments?

call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REGULAR STRENGTH STOMACH RELIEF 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-204
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink (Light pink to pink)	Score	no score
Shape	ROUND	Size	15mm
Flavor		Imprint Code	118
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-204-30	5 in 1 CARTON	09/18/2023
1		6 in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M008	09/18/2023

Labeler - DOLGENCORP, INC. (068331990)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
Marksans Pharma Ltd		925822975	manufacture(55910-204)