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Stomach Relief by WALGREEN CO.

Dosage form: capsule
Ingredients: BISMUTH SUBSALICYLATE 262mg
Labeler: WALGREEN CO.
NDC Code: 0363-0346

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:

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

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:

  • 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
  • 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
  • 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 1/2 to 1 hour as needed.  Do not exceend 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
  • each caplet contains: calcium 20 mg, salicylate 103 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat
  • see end flap for expiration date and lot number 

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



STOMACH RELIEF 
bismuth subsalicylate capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0346
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 
D&C RED NO. 30 
CALCIUM CARBONATE 
MANNITOL 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code44;346
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0346-101 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
140 CAPSULE (40 CAPSULE) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33505/06/2011
Labeler - WALGREEN CO. (008965063)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0363-0346)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0363-0346)

Revised: 07/2013
 
WALGREEN CO.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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