Stomach Relief
FDA Label NDC 66424-045

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sda Laboratories, Inc. for the product Stomach Relief (NDC 66424-045). 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 tablet), 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 Tablet)

Bismuth subsalicylate 262mg

Purposes

Anti-diarrheal/ Upset stomach reliever

Uses

  • controls diarrhea
  • relieves upset stomach due to overindulgence in food or drink

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 symtoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: 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
  • if you have an ulcer or 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

talking 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.

Directions

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • repeat dosage every 1/2 to 1 hour as needed
  • do not take more than 8 doses in 24 hours
  • use untill diarrhea stops but not more than 2 days
  • adults and children 12 years and over: 2 tablets
  • children under 12 years: ask a doctor

Other Information

  • each tablet contains: calcium 77 mg, salicylate 102 mg
  • store at 15 to 300C (59 to 860F)
  • protect from moisture

Inactive Ingredients

calcium carbonate, D&C red #27(Al-lake), dextrose, flavor(cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions Or Comments?

Adverse drug event call 1-(714)-903-7952

Principal Display Panel

NDC 66424-045-30

Stomach Relief

Bismuth Subsalicylate 262 mg

Anti-Diarrheal/ Upset Stomach Reliever

Helps to Relieve:

  • Upset Stomach
  • Diarrhea
  • Indigestion
  • Heartburn
  • Nausea

    • †Compare to the Active Ingredients in Pepto-Bismol

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

    †This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark Pepto-Bismol

* Please review the disclaimer below.