FDA.reportPublic FDA data

Equaline Stomach Relief

Manufacturer
UNITED NATURAL FOODS, INC. DBA UNFI | Guardian Drug Company
Effective date
2024-12-20
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-06-01 00:47:54

Label at a glance#

ProductEqualine Stomach Relief
Active ingredientBISMUTH SUBSALICYLATE
Label structure15 sections

Dosage and administration

shake well before use mL = milliliter TBSP = tablespoon adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every 1/2 to 1 hour as needed do not exceed 8 doses (16 TBSP or 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 fluids to help prevent dehydration caused by diarrhea

Storage and handling

each 30 mL or 2 TBSP contains: potassium 25 mg salicylate 260 mg sodium 8 mg protect from freezing avoid excessive heat (over 104 o F or 40 o C) dosage cup provided

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 mg


PURPOSE

OTC - PURPOSE SECTION

Upset stomach reliever and anti-diarrheal

USE(S)

INDICATIONS & USAGE SECTION

relieves:


  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • 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 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

OTC - DO NOT USE SECTION

  • an ulcer
  • bloody or black stool
  • 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 immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • mL = milliliter
  • TBSP = tablespoon
  • adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 TBSP or 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 fluids to help prevent dehydration caused by diarrhea

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • each 30 mL or 2 TBSP contains:
  • potassium 25 mg
  • salicylate 260 mg
  • sodium 8 mg
  • protect from freezing
  • avoid excessive heat (over 104oF or 40oC)
  • dosage cup provided

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41163-936-06
compare to Pepto-Bismol® active ingredient*
EQUALINE
original strength
stomach relief liquid
bismuth subsalicylate 525 mg per 30 mL
(upset stomach reliever/antidiarrheal)

5 symptom digestive relief:


  • heartburn
  • indigestion
  • nausea
  • upset stomach
  • diarrhea

16 FL OZ (1 pt) 473 mL


527-Equaline-16
527-Equaline-16


DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN3
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD3
308762bismuth subsalicylate 1.75 % Oral SuspensionSY3
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY3
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY3
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-936-04Equaline Stomach Relief237 mL in 1 BOTTLELIQUID2373
41163-936-05Equaline Stomach Relief354 mL in 1 BOTTLELIQUID3543
41163-936-06Equaline Stomach Relief473 mL in 1 BOTTLELIQUID4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-936EQUALINE STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [UNITED NATURAL FOODS, INC. DBA UNFI]3Current NDC, Legacy NDC, 3 package rows20241222_d0607a4e-de81-4881-abc7-cf0cc72a9f92.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41163-93641163-936-05, 41163-936-06, 41163-936-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
BENZOIC ACID8SKN0B0MIMIACT
D&C RED NO. 221678RKX8RTIACT
D&C RED NO. 28767IP0Y5NHIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SALICYLIC ACIDO414PZ4LPZIACT
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)L605B5892VIACT
DIMETHICONE92RU3N3Y1OIACT
XANTHAN GUMTTV12P4NEEIACT

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 UNFId0607a4e-de81-4881-abc7-cf0cc72a9f922024-12-20WarningsExact identifier
ndc (package): 41163-936-04
ndc (package): 41163-936-06
ndc (package): 41163-936-05
ndc (product): 41163-936
ndc11 (package): 41163093605
ndc11 (package): 41163093604
ndc11 (package): 41163093606
spl id: 1d41e236-c9ed-4d63-8cbb-185ce342f53e
spl set id: d0607a4e-de81-4881-abc7-cf0cc72a9f92

Reported adverse events (FAERS/openFDA)#

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