Topcare Stomach Relief Suspension
FDA Label NDC 36800-341

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 Stomach Relief (NDC 36800-341). 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 dose), purposes, uses, 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 Dose)

Bismuth subsalicylate 525 mg

Purposes

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
  • ▪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 or 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 at (1-800-222-1222).

Directions

  • ▪shake well before use
  • ▪Only use dose cup provided
  • ▪adults and children 12 years and over: 15 mL (1 dose) every 1/2 or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea.
  • ▪15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • ▪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 clear fluids to help prevent dehydration caused by diarrhea

Other Information

  • each 15 mL contains: sodium 10 mg
  • salicylate 230 mg
  • low sodium
  • sugar free
  • store at room temperature
  • protect from freezing
  • avoid excessive heat (over 104°F or 40°C)

Inactive Ingredients

carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum

Questions Or Comments?

1-888-423-0139

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN.

Principal Display Panel

TopCare® health™

COMPARE TO PEPTO-BISMOL® ULTRA STRENGTH ACTIVE INGREDIENT*

ULTRA STRENGTH

Stomach Relief

Bismuth Subsalicylate 1050 mg per 30 mL

UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5 SYSMPTOM DIGESTIVE RELIEF

  • Heartburn
  • Indigestion
  • Upset Stomach
  • Nausea
  • Diarrhea

    • OUR PHARMACISTS RECOMMEND

    QUALITY GURANTEED

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 6007

    TOPCO RARA0918

    QUESTIONS? 1-888-423-0139

    [email protected], www.topcarebrand.com

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-Bismol®.

    Package Label 354 mL

* Please review the disclaimer below.