Soothe

Manufacturer
Walgreens
Effective date
2024-07-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:16:02

Label at a glance#

ProductSoothe
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections

Indications and uses

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

Dosage and administration

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 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 of age: ask a doctor drink plenty of clear fluids to help prevent dehydr...

Storage and handling

each 30 mL contains : sodium 6 mg each 30 mL contains : salicylate 243 mg low sodium keep tightly closed protect from freezing avoid excessive heat (over 104ºF or 40ºC)

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/Antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves

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

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any drug for

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

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 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of childen.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 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 of age: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: sodium 6 mg
  • each 30 mL contains: salicylate 243 mg
  • low sodium
  • keep tightly closed
  • protect from freezing
  • avoid excessive heat (over 104ºF or 40ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Pepto-Bismol® active ingredient††

Soothe®

BISMUTH SUBSALICYLATE  525mg /

UPSET STOMACH RELIEVER  /

ANTIDIARRHEAL

SUGAR FREE  ALCOHOL FREE

  • Provides protective coating action to relieves heartburn, indigestion, nausea, upset stomach & diarrhea

FL OZ (mL)

≠≠This product is not manufactured or distributed by Procter & Gamble Company, Pepto-Bismol® is a registered trademark of The Protecter & Gamble Company.

TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD, DEERFIELD, IL 60015

walgreens.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WALGREENS Soothe
WALGREENS Soothe

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN6
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD6
308762bismuth subsalicylate 1.75 % Oral SuspensionSY6
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY6
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY6
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
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
0363-0073-08Soothe237 mL in 1 BOTTLE, PLASTICLIQUID2376
0363-0073-16Soothe473 mL in 1 BOTTLE, PLASTICLIQUID4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0073SOOTHE (BISMUTH SUBSALICYLATE) LIQUID [WALGREENS]6Current NDC, Legacy NDC, 2 package rows20240726_a2b2b0ce-034e-4857-bfca-0087bb31878e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0073-08ML - Milliliter0363-0073d3e745d2-731b-47cb-9842-0875d425495b12022-06-06
0363-0073-16ML - Milliliter0363-0073282791b9-15f8-4fb7-b333-35d74b923da212022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR12
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM2
D&C RED NO. 22INACTIVE INGREDIENT1678RKX8RT2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NH2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC2
METHYLCELLULOSE (1500 MPA.S)INACTIVE INGREDIENTP0NTE483642
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY2
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ2
SODIUM SALICYLATEINACTIVE INGREDIENTWIQ1H85SYP2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-00730363-0073-08, 0363-0073-16

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 · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 84 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHSUSPENSION / ORAL2.5 mg/5mlExact identifier — unii+route
27 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, COATED / ORAL1 mgExact identifier — unii+route
30 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / ORAL10 mgExact identifier — unii+route
30 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCONCENTRATE / ORAL1 mgExact identifier — unii+route
30 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, FILM COATED / ORAL5 mgExact identifier — unii+route
30 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, COATED / ORAL1 mgExact identifier — unii+route
30 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTTABLET, COATED / ORALNAExact identifier — unii+route
15 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, CHEWABLE / ORALNAExact identifier — unii+route
30 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTCAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii+route
15 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
27 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
27 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCONCENTRATE / ORAL1 mgExact identifier — unii+route
30 equally ranked IID candidates
METHYLCELLULOSE (1500 MPA.S)METHYLCELLULOSE (1500 MPA.S)P0NTE48364TABLET / ORAL319 mgExact identifier — unii+route
3 equally ranked IID candidates
METHYLCELLULOSE (1500 MPA.S)METHYLCELLULOSE (1500 MPA.S)P0NTE48364TABLET / ORAL319 mgExact identifier — unii+route
3 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTTABLET, DELAYED RELEASE / ORAL0.38 mgExact identifier — unii+route
15 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE / ORAL1 mgExact identifier — unii+route
27 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHPOWDER, FOR SOLUTION / ORAL3 mgExact identifier — unii+route
27 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, CHEWABLE / ORALNAExact identifier — unii+route
30 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / ORAL10 mgExact identifier — unii+route
30 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii+route
27 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTCAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii+route
15 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTCAPSULE / ORAL0.02 mgExact identifier — unii+route
15 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTTABLET, COATED / ORALNAExact identifier — unii+route
15 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, COATED / ORAL1 mgExact identifier — unii+route
30 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHPOWDER, FOR SUSPENSION / ORAL0.7 mg/5mlExact identifier — unii+route
27 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
27 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHTABLET / ORALNAExact identifier — unii+route
27 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLIQUID / ORAL2 mg/1mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHSUSPENSION / ORAL2.5 mg/5mlExact identifier — unii+route
27 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCLIQUID / ORAL82 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSYRUP / ORAL80 mgExact identifier — unii+route
30 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / ORAL10 mgExact identifier — unii+route
30 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHPOWDER, FOR SOLUTION / ORAL3 mgExact identifier — unii+route
27 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCONCENTRATE / ORAL1 mgExact identifier — unii+route
30 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
27 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHPOWDER, FOR SUSPENSION / ORAL0.7 mg/5mlExact identifier — unii+route
27 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHPOWDER, FOR SOLUTION / ORAL3 mgExact identifier — unii+route
27 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
27 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
27 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
27 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSYRUP / ORAL80 mgExact identifier — unii+route
30 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTSUSPENSION / ORALNAExact identifier — unii+route
15 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE / ORAL1 mgExact identifier — unii+route
27 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTCAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii+route
15 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLIQUID / ORAL2 mg/1mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, FILM COATED, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
30 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii+route
27 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii+route
27 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSYRUP / ORAL80 mgExact identifier — unii+route
30 equally ranked IID candidates
METHYLCELLULOSE (1500 MPA.S)METHYLCELLULOSE (1500 MPA.S)P0NTE48364TABLET / ORAL319 mgExact identifier — unii+route
3 equally ranked IID candidates
D&C RED NO. 22D&C RED NO. 221678RKX8RTCAPSULE / ORAL0.02 mgExact identifier — unii+route
15 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHPOWDER, FOR SUSPENSION / ORAL0.7 mg/5mlExact identifier — unii+route
27 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCLIQUID / ORAL82 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, FILM COATED / ORAL5 mgExact identifier — unii+route
30 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHSUSPENSION / ORAL2.5 mg/5mlExact identifier — unii+route
27 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
27 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, FILM COATED, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
30 equally ranked IID candidates

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
SootheBISMUTH SUBSALICYLATEWalgreensa2b2b0ce-034e-4857-bfca-0087bb31878e2024-07-25WarningsExact identifier
ndc (package): 0363-0073-16
ndc (package): 0363-0073-08
ndc (product): 0363-0073
ndc11 (package): 00363007308
ndc11 (package): 00363007316
spl id: 8451f30d-bd04-44e4-b0c1-29d9b04ecadc
spl set id: a2b2b0ce-034e-4857-bfca-0087bb31878e

Reported adverse events (FAERS/openFDA)#

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