Topcare Ultra Strength Stomach Relief Liquid
FDA Label NDC 76162-022

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Topcare Ultra Strength Stomach Relief (NDC 76162-022). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(in each 15 ml), purpose, use(s), warnings, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(In Each 15 Ml)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and anti-diarrheal

Use(S)

relieves:


  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • 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 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
  • bloody or black stool
  • 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 immediately.

Directions

  • shake well before use
  • mL = milliliter
  • TBSP = tablespoon
  • adults and children 12 years and over: 1 dose (1 TBSP or 15 mL) every 1/2 hour as needed
  • do not exceed 8 doses (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 fluids to help prevent dehydration caused by diarrhea

Other Information

  • each 15 mL or 1 TBSP contains:
  • potassium 15 mg
  • salicylate 236 mg
  • sodium 5 mg
  • protect from freezing
  • avoid excessive heat (over 104oF or 40oC)
  • dosage cup provided

Inactive Ingredients

benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum

Principal Display Panel

NDC 76162-022-05
COMPARE TO PEPTO-BISMOL® ULTRA STRENGTH ACTIVE INGREDIENT*
TopCare
ULTRA STRENGTH
Stomach Relief
BISMUTH SUBSALICYLATE 525 mg per 15 mL
UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5 SYMPTOM DIGESTIVE RELIEF


  • Heartburn
  • Indigestion
  • Nausea
  • Upset stomach
  • Diarrhea

    • 12 FL OZ (354 mL)


    103 (528)

    103 (528)




* Please review the disclaimer below.