Chewable Stomach Relief Tablet, Chewable
FDA Label NDC 41415-124

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets Inc, for the product Chewable Stomach Relief (NDC 41415-124). 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 other, active ingredient (in each chewable tablet), purpose, uses, reye's syndrome, allergy alert, otc - do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Chewable Tablet)

Bismuth subsalicylate 262 mg

Purpose

Antidiarrheal/ upset stomach reliever

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness

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

Do not use if you are

  • allergic to salicylate (including aspirin)
  • taking other salicylate products

Otc - Do Not Use

Do not use if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Otc - Ask Doctor

Ask a doctor before use if you have

  • fever
  • mucus in the stool

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking any drug for

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Otc - When Using

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222

Directions

  • chew or dissolve tablets 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
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • children under 12 years: ask a doctor

Other Information

  • each tablet contains: salicylate 102 mg
  • Store at room temperature
  • avoid excessive heat
  • keep this carton for future reference on full labeling

Inactive Ingredients

flavor, magnesium stearate, microcrystalline cellulose, red #27 aluminum lake, sorbitol, sucralose.

Questions Or Comments?

1-866-467-2748

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Compare to active ingredient in Pepto-Bismol® Chewable Tablets*

Pink bismuth chewable tablets

Original flavor

bismuth subsalicylate 262mg/antidiarrheal

upset stomach, indigestion ,nausea, heartburn, diarrhea

30 CHEWABLE TABLETS

DO NOT USE IF INDIVIDUAL BLISTER COMPARTMENTS ARE TORN OR OPEN

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

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

Publix.com

Publix Chewable Stomach Relief 30 Counts (Pepto Bismol 01)

Publix Chewable Stomach Relief 30 Counts (Pepto Bismol 01)

* Please review the disclaimer below.