Soothe

Manufacturer: Walgreen Company | LNK International, Inc.
Effective date: 2022-01-03
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: legacy-cache
Hydrated at: 2026-08-01 22:19:34

Label at a glance#

ProductSoothe

Active ingredientBISMUTH SUBSALICYLATE

Label structure9 sections

Indications and uses

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

Dosage and administration

swallow with water; do not chew drink plenty of clear fluids to help prevent dehydration caused by diarrhea adults and children 12 years and over: 2 caplets every ½ to 1 hour as needed. Do not exceed 8 doses (16 caplets) in 24 hours. use until diarrhea stops, but not more than 2 days children under 12 years: ask a doctor

Storage and handling

each caplet contains: calcium 20 mg, salicylate 103 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid excessive heat see end flap for expiration date and lot number

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-426-9391

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/antidiarrheal

Uses

INDICATIONS & USAGE SECTION

relieves:

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

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

anticoagulation (thinning the blood)
gout
diabetes
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 a 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

swallow with water; do not chew
drink plenty of clear fluids to help prevent dehydration caused by diarrhea
adults and children 12 years and over: 2 caplets every ½ to 1 hour as needed. Do not exceed 8 doses (16 caplets) in 24 hours.
use until diarrhea stops, but not more than 2 days
children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

each caplet contains: calcium 20 mg, salicylate 103 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
avoid excessive heat
see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

Compare to Pepto-Bismol®
active ingredient^††

NDC 0363-0346-10

Soothe®
BISMUTH SUBSALICYLATE 262 mg /
UPSET STOMACH RELIEVER /
ANTI-DIARRHEAL

• Multi-symptom relief of nausea, heartburn,
indigestion, upset stomach & diarrhea

40 CAPLETS

ACTUAL SIZE

Walgreens
PHARMACIST
RECOMMENDED^†

Health expertise
you rely on,
quality you trust.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

^†Walgreens Pharmacist Survey
^†† This product is not manufactured or
distributed by Procter & Gamble,
owner of the registered trademark
Pepto-Bismol®.

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2017 Walgreen Co.

50844 ORG101634610

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-0346-10	EA - Each	0363-0346	3ef6e349-a317-4212-9382-99196b6ef247	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	2
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	2
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Soothe
Bismuth Subsalicylate
SALICYLIC ACID
BISMUTH CATION
D&C RED NO. 27 ALUMINUM LAKE
D&C RED NO. 30
CALCIUM CARBONATE
MANNITOL
MAGNESIUM STEARATE
STARCH, CORN
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0363-0346	0363-0346-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BISMUTH SUBSALICYLATE	62TEY51RR1	ACTIB
D&C RED NO. 27 ALUMINUM LAKE	ZK64F7XSTX	IACT
D&C RED NO. 30	2S42T2808B	IACT
CALCIUM CARBONATE	H0G9379FGK	IACT
MANNITOL	3OWL53L36A	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
STARCH, CORN	O8232NY3SJ	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STEARIC ACID	4ELV7Z65AP	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT

Source Document#

Source XML

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 · 91 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MANNITOL	MANNITOL	3OWL53L36A	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1568 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SOLUTION / SUBMUCOSAL	2.94 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION / INTRAVENOUS		15200 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	GRANULE / ORAL		1328 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / INTRAMUSCULAR	6.75 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
D&C RED NO. 30	D&C RED NO. 30	2S42T2808B	CAPSULE / ORAL	0.1 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / OPHTHALMIC	4.7 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, DELAYED RELEASE / ORAL		2043 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		15400 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, COATED / ORAL	64.8 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, DELAYED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	POWDER, DENTIFRICE / DENTAL	0.5 mg/mg		Exact identifier — unii candidate 15 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		164 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / ORAL		869 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE / ORAL		1562 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET, EXTENDED RELEASE / ORAL	1.43 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, EXTENDED RELEASE / ORAL	4 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION/ DROPS / OPHTHALMIC	3.3 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER / RESPIRATORY (INHALATION)		6 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION, EXTENDED RELEASE / ORAL	2464.6 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SUSPENSION / INTRAMUSCULAR		71 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
D&C RED NO. 30	D&C RED NO. 30	2S42T2808B	TABLET, COATED / ORAL	1.16 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION/ DROPS / OPHTHALMIC	4.6 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	POWDER, FOR SUSPENSION / ORAL	1.67 mg/5ml		Exact identifier — unii candidate 4 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, COATED PELLETS / ORAL		14 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	GUM, CHEWING / BUCCAL		3492 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SOLUTION / SUBCUTANEOUS		99 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL	10.25 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
D&C RED NO. 30	D&C RED NO. 30	2S42T2808B	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER / ORAL		4352 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, FILM COATED / ORAL		300 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
D&C RED NO. 30	D&C RED NO. 30	2S42T2808B	TABLET, FILM COATED / ORAL	0.26 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	GEL / OPHTHALMIC		25 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / TOPICAL	4 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / ORAL		7093 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SUSPENSION / INTRAVENOUS	2.5 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / BUCCAL		360 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, EXTENDED RELEASE / ORAL		1086 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	980.4 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	35 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SOLUTION / ORAL		3767 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL		3726 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, COATED / ORAL	177.7 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE / ORAL	349.9 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / ORAL		3391 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION, GEL FORMING / DROPS / OPHTHALMIC		4 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CONCENTRATE / INTRAVENOUS		220 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	WAFER / ORAL	642 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / SUBLINGUAL		495 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / INTRAVENOUS		15400 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		616 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION / SUBCUTANEOUS		675 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION/ DROPS / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
D&C RED NO. 30	D&C RED NO. 30	2S42T2808B	TABLET, CHEWABLE / ORAL		3 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TROCHE / ORAL		14594 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	FILM, SOLUBLE / ORAL		14 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	200 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, EXTENDED RELEASE / ORAL	229.7 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
D&C RED NO. 30	D&C RED NO. 30	2S42T2808B	TABLET, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 7 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
53acb67e-d761-4883-9dca-a288715b60e1			63721ab2-86b1-481a-8596-2a178b444de2	2023-01-27	Warnings	Exact identifier spl set id: 63721ab2-86b1-481a-8596-2a178b444de2

Reported adverse events (FAERS/openFDA)#

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