Stomach Relief

Manufacturer
Harmon Store Inc. | LNK International, Inc.
Effective date
2020-03-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:39:35

Label at a glance#

ProductStomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections

Indications and uses

relieves: diarrhea traveler's diarrhea upset stomach due to overindulgence in food and drink, including: indigestion nausea heartburn belching fullness gas

Dosage and administration

chew or crush tablets completely before swallowing; do not swallow tablets whole drink plenty of clear fluids to help prevent dehydration caused by diarrhea adults and children 12 years and over: 2 chewable tablets every 1/2 to 1 hour as needed. Do not exceed 16 chewable tablets in 24 hours. do not use for more than 2 days unless directed by a doctor use until diarrhea stops, but not more than 2 days children unde...

Storage and handling

each tablet contains: calcium 40 mg, salicylate 102 mg TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF CELLOPHANE UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING see end flap for expiration date and lot number store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid excessive heat store in a dry place

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg 

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever/antidiarrheal 

Uses

INDICATIONS & USAGE SECTION

relieves:

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

Warnings

WARNINGS SECTION

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 product

Do not use

OTC - DO NOT USE SECTION

if you have

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool 

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for

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

When using this product

OTC - WHEN USING SECTION

a temporary, but harmless, darkening of the stool and/or tongue may occur. 

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • diarrhea lasts more than 2 days
  • ringing in the ears or loss of hearing occurs
  • symptoms get worse

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. 

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • adults and children 12 years and over: 2 chewable tablets every 1/2 to 1 hour as needed. Do not exceed 16 chewable tablets in 24 hours.
  • do not use for more than 2 days unless directed by a doctor
  • use until diarrhea stops, but not more than 2 days
  • children under 12 years: ask a doctor 

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 40 mg, salicylate 102 mg
  • TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF CELLOPHANE UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
  • see end flap for expiration date and lot number
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat
  • store in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, cherry flavor, D&C red #27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, mannitol, povidone, saccharin sodium, stearic acid, talc 

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CORE VALUES™

Compare to active ingredient in Pepto-Bismol®†

Stomach Relief

Bismuth subsalicylate 262 mg
Chewable Tablets
Upset Stomach Reliever/
Antidiarrheal

Relieves:
• Nausea
• Heartburn
• Indigestion
• Upset Stomach
• Diarrhea

Actual Size

Chew or crush tablets completely before swallowing.
Do not swallow tablets whole.

30 chewable tablets           cherry flavor

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF CELLOPHANE UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed by: Liberty Procurement, Inc.,
650 Liberty Ave., Union, NJ 07083 U.S.A
Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Pepto-Bismol®.
50844    REV0119A31901

Core Values 44-319
Core Values 44-319

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63940-31963940-319-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ac3b0af1-ad36-4660-9b6b-98d549eb59b45c990d28-3f73-453f-855d-48e7fec94b062021-03-18WarningsExact identifier
spl set id: 5c990d28-3f73-453f-855d-48e7fec94b06

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.