Topcare Stomach Relief

Dosage form: liquid
Ingredients: BISMUTH SUBSALICYLATE 525mg in 15mL
Labeler: Topco Associates LLC
NDC Code: 36800-337

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.

Topco Associates LLC. Stomach Relief Drug Facts

Active ingredient (in each 15 mL Tablespoon)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and antidiarrheal

Uses

relieves

  • travelers’ diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching

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
  • 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
  • shake well before use
  • for accurate dosing, use dose cup
  • TBSP = Tablespoonful
  • adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every hour as needed
  • do not exceed 4 doses (8 TBSP or 120 mL) 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 TBSP contains: magnesium 5 mg, potassium 5 mg and sodium 5 mg
  • salicylate 230 mg
  • low sodium
  • sugar free
  • protect from freezing
  • for health information visit www.more-info.info

Inactive ingredients

D&C red #22, D&C red #28, magnesium aluminum silicate, methyl salicylate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gum

Questions or comments?

1-888-423-0139

Principal Display Panel

2X STRENGTH

MAXIMUM STRENGTH

Stomach Relief

BISMUTH SUBSALICYLATE 525 mg

UPSET STOMACH RELIEVER/ANTIDIARRHEAL

PROTECTIVE COATING ACTION

5 Symptom relief of:

Heartburn

Indigestion

Upset Stomach

Nausea

Diarrhea

COMPARE TO PEPTO-BISMOL® MAX STRENGTH active ingredient

Stomach Relief Label

TOPCARE STOMACH RELIEF 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-337
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (BISMUTH SUBSALICYLATE) BISMUTH SUBSALICYLATE525 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 22 
D&C RED NO. 28 
MAGNESIUM ALUMINUM SILICATE 
METHYL SALICYLATE 
WATER 
SACCHARIN SODIUM 
SALICYLIC ACID 
SODIUM SALICYLATE 
SORBIC ACID 
XANTHAN GUM 
Product Characteristics
ColorPINK (viscous) Score    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-337-34237 mL in 1 BOTTLE
2NDC:36800-337-40355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33512/15/1989
Labeler - Topco Associates LLC (006935977)

Revised: 01/2012
 
Topco Associates LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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