TOPCO STOMACH RELIEF- bismuth subsalicylate tablet

Topco Stomach Relief by

Drug Labeling and Warnings

Topco Stomach Relief by is a Otc medication manufactured, distributed, or labeled by Topco Associates, LLC, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(in each caplet)

Bismuth subsalicylate 262 mg

PURPOSE

Upset stomach reliever and anti-diarrheal

USE(S)

relieves:

• indigestion
• nausea
• heartburn
• diarrhea
• upset stomach associated with these symptoms

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 behaviour 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

• bloody or black stool
• an ulcer
• a bleeding problem

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 may occur

STOP USE AND ASK DOCTOR IF

• symptoms get worse
• 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.

DIRECTIONS

• swallow caplet(s) with water, do not chew
• adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
• do not take more than 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 caplet contains:
• calcium 27 mg, salicylate 102 mg and sodium 2 mg
• very low sodium
• TAMPER EVIDENT: do not use if printed seal under cap is torn or missing 
• store at room temperature, in a dry place

INACTIVE INGREDIENTS

calcium carbonate, colloidal silicon dioxide, D&C red 27 lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate.

PRINCIPAL DISPLAY PANEL

Topcare health

COMPATE TO PEPTO-BISMOL®  ACTIVE INGREDIENT*

NDC: 36800-104-28

Stomach Relief
BISMUTH SUBSALICYLATE 262 mg
UPSET STOMACH RELIEVER / ANTIDIARRHEAL

5 SYMPTOM RELIEF 

• Nausea
• Heartburn
• Indigestion
• Upset stomach
• Diarrhea

40 CAPLETS

INGREDIENTS AND APPEARANCE

TOPCO STOMACH RELIEF 
bismuth subsalicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-104
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	G;172
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-104-28	1 in 1 CARTON	10/01/2020
1		40 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	10/01/2020

Labeler - Topco Associates, LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(36800-104)