OTC Medication Information: Regular Strength Stomach Relief

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.

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:

• 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 information

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

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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (SALICYLIC ACID and BISMUTH CATION) BISMUTH SUBSALICYLATE 262 mg

Inactive Ingredients Ingredient Name Strength D&C RED NO. 27 ALUMINUM LAKE MANNITOL POVIDONE TALC MAGNESIUM STEARATE SACCHARIN SODIUM CALCIUM CARBONATE

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 Multilevel Packaging 1 NDC:55910-204-30 5 CELLO PACK in 1 CARTON contains a CELLO PACK 1 6 TABLET, CHEWABLE in 1 CELLO PACK This package is contained within the CARTON (55910-204-30)

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	Operations
Marksans Pharma Ltd		925822975	manufacture (55910-204)

Revised: 09/2023 DOLGENCORP, INC.