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Stomach Relief

Drug Facts

Approved
Approval ID

5c02d0ba-91e4-4bd2-ac66-6905323653b2

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 12, 2025

Manufacturers
FDA

ATLANTIC BIOLOGICALS CORP.

DUNS: 047437707

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Bismuth subsalicylate

PRODUCT DETAILS

NDC Product Code17856-1286
Application NumberM
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 12, 2025
Generic NameBismuth subsalicylate

INGREDIENTS (8)

XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
BISMUTH SUBSALICYLATEActive
Quantity: 525 mg in 30 mL
Code: 62TEY51RR1
Classification: ACTIB
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
D&C RED NO. 22Inactive
Code: 1678RKX8RT
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/19/2024

Principal Display Panel

Compare to the active ingredient in Pepto-Bismol®*

Regular Strength

Stomach Relief

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

Relieves:

• Heartburn • Indigestion • Nausea

Alcohol Free • Sugar Free

image description

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INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/1/2020

Uses

relieves

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/19/2024

Active ingredient (in each 30 mL dose)

Bismuth subsalicylate 525 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/1/2020

Purpose

Upset stomach reliever/Antidiarrheal

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/1/2020

Questions or comments?

Call1-800-645-2158

Distributed by:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16th PLACE

MIAMI, FL 33179

WARNINGS SECTION

LOINC: 34071-1Updated: 10/1/2020

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 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

if you have

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

Ask a doctor before use if you have

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you are

taking any drug for

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

When using this product

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

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of childen.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/1/2020

Directions

  • mL = milliliter
  • shake well before using
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • adults and children 12 years and over
    • 30 mL (1 dose) every 1/2 or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
    • 30 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
    • do not exceed 8 doses (240 mL) in 24 hours
    • use until diarrhea stops but not more than 2 days
  • children under 12 years of age: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 10/1/2020

Other information

*each 30 mL contains: potassium 8 mg sodium 9 mg *each 30 mL contains: salicylate 206 mg

  • low sodium
  • keep tightly closed
  • protect from freezing
  • avoid excessive heat (over 104ºF or 40ºC)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/1/2020

Inactive ingredients

benzoic acid, D&C red #22, D&C red #28, flavor, glycerin, purified water, sucralose, xanthan gum

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Stomach Relief - FDA Drug Approval Details