STOMACH RELIEF- bismuth subsalicylate capsule 
WALGREEN CO.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Walgreens 44-346

Active ingredient (in each caplet)

Bismuth subsalicylate 262 mg 

Purpose

Upset stomach reliever/Antidiarrheal 

Uses

relieves:

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 vomitin goccur, 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:

Do not use

if you have

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

Ask a doctor before use if

  • fever
  • mucus in the stool 

Ask a doctor or pharmacist before use if you are

taking any drug for

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

  • 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,

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

Other information

Inactive ingredients

calcium carbonate, D&C red #27 aluminium lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicia gel, sodium starch glycolate, stearic acid 

Questions or comments?

 1-800-426-9391

Principal display panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0346-10

Soothe®
Bismuth Subsalicylate 262 mg
Upset Stomach Reliever / Antidiarrheal
Multi-symptom relief of:
• Nausea • Heartburn
• Indigestion
• Upset stomach
• Diarrhea

40
CAPLETS

Compare to Pepto-Bismol® active ingredientǂǂ

ǂWalgreens Pharmacist Survey Study, November 2012.
ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare,owner of the registered trademark Tylenol® Extra Strength Caplets.
50844    ORG021317512

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

Walgreens 44-346

Walgreens 44-346



STOMACH RELIEF 
bismuth subsalicylate capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0346
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 262 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code 44;346
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0363-0346-10 1 in 1 CARTON
1 40 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part335 05/06/2011
Labeler - WALGREEN CO. (008965063)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(0363-0346)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(0363-0346)

Revised: 7/2013
Document Id: e5597e1b-6b4f-4321-8b5e-4f07a4cae307
Set id: 63721ab2-86b1-481a-8596-2a178b444de2
Version: 1
Effective Time: 20130709
 
WALGREEN CO.