Peptic Relief
FDA Label NDC 54868-2898

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Peptic Relief (NDC 54868-2898). 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 tablespoon), purposes, uses, warnings, do not use, 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 Tablespoon)

Bismuth subsalicylate 262 mg

Purposes

Upset stomach reliever/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 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
  • adults and children 12 years and over: 1 dose (2 Tbsp or 30 mL) every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 Tbsp or 240 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 123 mg
  • protect from freezing
  • sugar free
  • low sodium
  • store at 20°-25°C (68°-77°F)
  • does not meet USP requirements for pH
  • for health information visit www.more-info.info

Inactive Ingredients

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

Questions Or Comments?

1-800-719-9260

Other

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma        74146

Principal Display Panel

Original Strength

Stomach Relief

Bismuth Subsalicylate 262 mg

Antidiarrheal/Upset Stomach Reliever

Protective Coating Action

Soothing Relief for 5 Symptoms:

  • Upset Stomach
  • Indigestion
  • Heartburn
  • Nausea
  • Diarrhea

    • Compare to active ingredient of Pepto-Bismol®

    NDC 54868-2898-0
    237 mL
    Stomach Relief Label (2898)

    Stomach Relief Label (2898)


    Stomach Relief Label

* Please review the disclaimer below.