FDA.reportPublic FDA data

Equaline Stomach Relief

Manufacturer
UNITED NATURAL FOODS, INC. DBA UNFI | Guardian Drug Company
Effective date
2024-05-12
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:24

Label at a glance#

ProductEqualine Stomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure15 sections

Dosage and administration

swallow caplet(s) with water, do not chew adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed do not take more than 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 caplet contains: calcium 27 mg, salicylate 102 mg and sodium 2 mg very low sodium TAMPER EVIDENT: do not use if printed seal under cap is torn or missing  store at room temperature, in a dry place

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 262 mg



PURPOSE

OTC - PURPOSE SECTION

Upset stomach reliever and anti-diarrheal

USE(S)

INDICATIONS & USAGE SECTION

relieves:


  • indigestion
  • nausea
  • heartburn
  • diarrhea
  • upset stomach associated with these symptoms

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 behaviour 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

OTC - DO NOT USE SECTION

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

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 of 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 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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • swallow caplet(s) with water, do not chew
  • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • do not take more than 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 caplet contains:
  • calcium 27 mg, salicylate 102 mg and sodium 2 mg
  • very low sodium
  • TAMPER EVIDENT: do not use if printed seal under cap is torn or missing 
  • store at room temperature, in a dry place

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

calcium carbonate, colloidal silicon dioxide, D&C red 27 lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EQUALINE

Compare to Pepto-Bismol®  active ingredient*

NDC 41163-123-28


Stomach Relief
bismuth subsalicylate 262 mg

anti-diarrheal/upset stomach reliever

relieves:

  • heartburn
  • nausea
  • Upset stomach
  • Indigestion
  • Diarrhea

40 CAPLETS   

172-equ-label.jpg172-equ-label.jpg

 




DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308760bismuth subsalicylate 262 MG Oral TabletPSN1
308760bismuth subsalicylate 262 MG Oral TabletSCD1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-123-28Equaline Stomach Relief1 in 1 CARTONTABLET11
41163-123-28Equaline Stomach Relief40 in 1 BOTTLETABLET401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-123EQUALINE STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET [UNITED NATURAL FOODS, INC. DBA UNFI]1Current NDC, 2 package rows20240514_a5767e55-97cc-4fe4-a431-668635e205af.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41163-12341163-123-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
CALCIUM CARBONATEH0G9379FGKIACT
D&C RED NO. 272LRS185U6KIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

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
Equaline Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFIa5767e55-97cc-4fe4-a431-668635e205af2024-05-12WarningsExact identifier
ndc (package): 41163-123-28
ndc (product): 41163-123
ndc11 (package): 41163012328
spl id: a5767e55-97cc-4fe4-a431-668635e205af
spl set id: a5767e55-97cc-4fe4-a431-668635e205af

Reported adverse events (FAERS/openFDA)#

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