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NDC 00363-0319-01 Soothe 262 mg/1 Details

Soothe 262 mg/1

Soothe is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is BISMUTH SUBSALICYLATE.

MedlinePlus Drug Summary

Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.

Related Packages: 00363-0319-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	00363-0319
Product ID	0363-0319_1d8ad42e-5ade-4f77-b0c3-0b506d9512ac
Associated GPIs	47300010000507
GCN Sequence Number	002860
GCN Sequence Number Description	bismuth subsalicylate TAB CHEW 262 MG ORAL
HIC3	D6D
HIC3 Description	ANTIDIARRHEALS
GCN	08420
HICL Sequence Number	001246
HICL Sequence Number Description	BISMUTH SUBSALICYLATE
Brand/Generic	Generic
Proprietary Name	Soothe
Proprietary Name Suffix	n/a
Non-Proprietary Name	BISMUTH SUBSALICYLATE
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	262
Active Ingredient Units	mg/1
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	Walgreen Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part335
Listing Certified Through	n/a

Package

Package Images

NDC 00363-0319-01 (00363031901)

Pricing Information	N/A
NDC Package Code	0363-0319-01
Billing NDC	00363031901
Package	5 BLISTER PACK in 1 CARTON (0363-0319-01) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	1998-07-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3f5ae065-3581-436a-9caa-17f41d886797 Details

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever/antidiarrheal

Uses

relieves:

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

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

anticoagulation (thinning the blood)
diabetes
gout
arthritis

When using this product

a temporary, but harmless, darkening of the stool and/or tongue may occur.

Stop use and ask a doctor if

ringing in the ears or loss of hearing occurs
symptoms get worse or last more than 2 days
diarrhea lasts more than 2 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

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

Directions

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

Other information

each tablet contains: calcium 40 mg, salicylate 102 mg
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF CELLOPHANE UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
see end flap for expiration date and lot number
store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
avoid excessive heat
store in a dry place

Inactive ingredients

calcium carbonate, cherry flavor, D&C red #27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, mannitol, povidone, saccharin sodium, stearic acid, talc

Questions or comments?

1-800-426-9391

Principal Display Panel

Walgreens

Compare to Pepto-Bismol®

active ingredient††

NDC 0363-0319-01

Soothe®

BISMUTH SUBSALICYLATE, 262 mg /

UPSET STOMACH RELIEVER / ANTI-DIARRHEAL

CHEWABLE

• Multi-symptom relief of nausea,

heartburn, indigestion,

upset stomach & diarrhea

NEW

LOOK

SAME GREAT

QUALITY

30

CHEWABLE

TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF

CELLOPHANE UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS

OF TAMPERING

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

††This product is not manufactured or distributed by

Procter & Gamble, owner of the registered trademark

Pepto-Bismol®.

50844 ORG021531901

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens

100% SATISFACTION

GUARANTEED

walgreens.com ©2017 Walgreen Co.

Walgreens 44-319

INGREDIENTS AND APPEARANCE

SOOTHE

bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0319
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	262 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY	Imprint Code	44;319
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0319-01	5 in 1 CARTON	07/16/1998	05/15/2023
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part335	07/16/1998	05/15/2023

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(0363-0319)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(0363-0319)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(0363-0319)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(0363-0319)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(0363-0319)

Revised: 5/2020

Document Id: 1d8ad42e-5ade-4f77-b0c3-0b506d9512ac

Set id: 3f5ae065-3581-436a-9caa-17f41d886797

Version: 15

Effective Time: 20200518