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Amazon Stomach Relief Tablets Drug Facts

Manufacturer
L. Perrigo Company
Effective date
2019-02-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:31:39

Label at a glance#

Productbasic care stomach relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure9 sections

Indications and uses

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

Dosage and administration

• chew or dissolve in mouth • adults and children 12 years and over: 2 tablets every ½ 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

Storage and handling

• each tablet contains: calcium 190 mg • salicylate 104 mg • very low sodium • store at 20-25 ° C (68-77 ° F). Avoid excessive heat over 104 ° F (40 ° C).

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg

Purposes

OTC - PURPOSE SECTION

Upset stomach reliever and antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

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

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 products

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

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

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 right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets every ½ 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

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 190 mg
  • salicylate 104 mg
  • very low sodium
  • store at 20-25°C (68-77°F). Avoid excessive heat over 104°F (40°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, D&C red #27 aluminum lake, flavor, magnesium stearate, mannitol, saccharin sodium, stearic acid

Questions?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5 Symptom Digestive Relief

Compare to Pepto-Bismol® active ingredient

stomach relief tablets

Bismuth Subsalicylate 262 mg

Upset Stomach Reliever/Antidiarrheal

Heartburn

Indigestion

Nausea

Upset Stomach

Diarrhea

actual size

30 CHEWABLE TABLETS

469AN-stomach-relief-tablets.jpg
469AN-stomach-relief-tablets.jpg

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0113-74690113-7469-65

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CALCIUM CARBONATEH0G9379FGKIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
STEARIC ACID4ELV7Z65APIACT
D&C RED NO. 272LRS185U6KIACT

Source Document#

Source XML

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
2befdf7d-d719-4ceb-bce9-89720283419759d7ccf2-bcb4-431a-b791-4afc841e64be2024-01-12WarningsExact identifier
spl set id: 59d7ccf2-bcb4-431a-b791-4afc841e64be

Reported adverse events (FAERS/openFDA)#

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