TOPCARE BISMUTH STOMACH RELIEF- bismuth tablet, chewable

TopCare Bismuth Stomach Relief by

Drug Labeling and Warnings

TopCare Bismuth Stomach Relief by is a Otc medication manufactured, distributed, or labeled by TopCo, SCNBestco, Betco. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each chewable tablet)

Bismuth subsalicylate 262 mg

PURPOSE

Purpose

Upset stomachreliever and antidiarrheal

INDICATIONS & USAGE

Uses relieves

• Traveler's diarrhea
• Diarrhea
• Upset stomach due to overindulgence in food or drink, ingluding
• Heartburn
• Indigestion
• Nausea
• Gas
• Belching
• Fullness

WARNINGS

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use the 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 rear but serious illness.

DO NOT USE

Allergy alert: Contains salicylate. Do not take if you are

• Allergic to salicylates (including aspirin)
• taking other salicylate products

DO NOT USE

Do not use if you have

An ulcer

A bleeding problem

Bloody or black stool

ASK DOCTOR

Ask a doctor before use if you have

• Fever
• Mucus in the stool

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking any drug for

• Anticoagulation (thinning the blood)
• Diabetes
• Gout
• Arthritis

WHEN USING

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

STOP USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Fully chew before swallowing
• Adults and children 12 years and over:
• 2 chewable tablets every 1/2 hour or 4 chewable tablets every hour as needed for diarrhea
• 2 chewable tablets every 1/2 hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea).
• Do not exceed 8 doses (16 chewable 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.

INACTIVE INGREDIENT

Inactive ingredients: Beeswax, calcium carbonate, carmine, carnauba wax, citric acid, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glycerin, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, natural and artificial flavors, phosphoric acid, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose, titanium dioxide, vegetable oil (coconut and/or canola oil), water.

OTHER SAFETY INFORMATION

Other information

• Each chewable tablet contains: Calcium 50 mg
• Salicylate 123 mg
• Contains soy
• Store between 20° to 25°C (68° to 77°F) in a dry place. Avoid excessive heat (over 40°C).

QUESTIONS

Questions? Call 1-800-245-2989 Mon - Fri, 9AM - 4PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE BISMUTH STOMACH RELIEF 
bismuth tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-406
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	19mm
Flavor	MINT	Imprint Code	SR
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-406-24	24 in 1 BOTTLE; Type 0: Not a Combination Product	03/17/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	03/17/2025

Labeler - TopCo (006935977)

Registrant - SCNBestco (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Betco		002149136	manufacture(76162-406)