Stomach Relief Tablet, Chewable
FDA Label NDC 51013-321

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Stomach Relief (NDC 51013-321). 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 drug facts, active ingredient (in each tablet), 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 taking any drug for, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Tablet)

Bismuth subsalicylate 262 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 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

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

Directions

  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 tablets) 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 tablet contains: calcium 77 mg, salicylate 102 mg
  • store at 15°-30°C (59°-86°F)
  • 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

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Principal Display Panel

Stomach Relief

30 Tablets   15 Pouches (2 Tablets per Pouch)

NDC: 51013-321-54

Cvsf34-00 (Cvsf34 00)

Cvsf34-00 (Cvsf34 00)

Cvsb34-00 (Cvsb34 00)

Cvsb34-00 (Cvsb34 00)

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