Chewable stomach relief tablet, chewable

Spl unclassified section

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

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

Do not use if you are

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

Otc - do not use section

Do not use ifyou have

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

Otc - ask doctor section

Ask a doctor before use if you have

  • fever
  • mucus in the stool

Otc - ask doctor/pharmacist section

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

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

Otc - when using section

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

Otc - stop use section

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 section

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

Otc - keep out of reach of children section

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

Ingredients and appearance - Product information

Chewable stomach relief tablet, chewable- Bismuth subsalicylate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 41415-124
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Bismuth subsalicylate ( UNII: 62TEY51RR1)( Bismuth cation - UNII: ZS9CD1I8YE ) 262 mgin 1

Inactive Ingredients

Ingredient Name Code
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
D&c red no. 27 ( UNII: 2LRS185U6K)
Sorbitol ( UNII: 506T60A25R)
Sucralose ( UNII: 96K6UQ3ZD4)

Product Characteristics

Color PINK (light-pink) Size 16 mm
Shape ROUND Score 1
Imprint Code RP124 Flavor WINTERGREEN

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part335 USA

Labeler - PUBLIX SUPER MARKETS INC,( 006922009)

Principal display panel

Compare toactive 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