Stomach Relief

Manufacturer
Aurohealth LLC
Effective date
2020-11-27
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:04:43

Label at a glance#

ProductStomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure12 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

shake well before use mL=milliliter measure only with dosing cup provided. Do not use any other dosing device  adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed do not exceed 8 doses (240 mL) 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 informati...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 30 mL dose cup)

Bismuth subsalicylate 525 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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool.

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product 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 or last more than 2 days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

If pregnant or breast-feeding, 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

  • shake well before use
  • mL=milliliter
  • measure only with dosing cup provided. Do not use any other dosing device 
  • adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed
  • do not exceed 8 doses (240 mL) 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 30 mL dose cup contains: magnesium 12 mg, sodium 7 mg
  • salicylate 233 mg
  • low sodium
  • Store at 20° to 25°C (68° to 77°F)and protect from freezing
  • avoid excessive heat (over 104°F or 40°C)

  • TAMPER EVIDENT: Do not use if the printed seal under the cap is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION


benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, magnesium aluminum silicate type 1C, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gum

Questions or comments?

1-855-274-4122

* This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-BismolTM.

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 16 FL OZ (473 mL) Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-516-26
Primary Health
COMPARE TO Pepto-BismolTM
active ingredient*
Stomach Relief
Bismuth Subsalicylate Liquid
Upset Stomach Reliever/
Antidiarrheal
Each 30 mL dose of oral solution contains:
525 mg - Bismuth subsalicylate
5 Symptom Digestive Relief

  • Heartburn
  • Indigestion
  • Nausea
  • Upset stomach
  • Diarrhea

Original Flavor
16 FL OZ (473 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 16 FL OZ (473 mL) BottlePACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 16 FL OZ (473 mL) Bottle


Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-51658602-516-26

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

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
361f10b7-f81d-43fd-9197-bfb7f0f52c2efb40c8eb-c4ca-4d65-93b0-7b7ff5ef3c4f2020-11-27WarningsExact identifier
spl id: 361f10b7-f81d-43fd-9197-bfb7f0f52c2e
spl set id: fb40c8eb-c4ca-4d65-93b0-7b7ff5ef3c4f

Reported adverse events (FAERS/openFDA)#

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