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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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code17856-1286
Application NumberM
Product Classification
M
Marketing Category
C200263
G
Generic Name
Bismuth subsalicylate
Product Specifications
Route of AdministrationORAL
Effective DateMay 12, 2025
FDA Product Classification

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

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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