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Soothe

WALGREEN CO.

Walgreens 44-319


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever/Antidiarrheal

Soothe Uses

relieves:

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

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

  • fever

  • mucus in the stool

Ask a doctor or pharmacist before use if you are

taking any drug for

  • anticoagulation (thinning of 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 of the ears or loss of hearing occurs
  • symptoms get worse or lasts 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 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

Soothe Other information

  • store in a dry place

  • each tablet contains: calcium 40 mg, salicylate 102 mg

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

  • avoid excessive heat

  • see end flap for expiration date and lot number

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

Product Packaging

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0319-01

Soothe®
Bismuth Subsalicylate, 262 mg
Upset Stomach Reliever
Antidiarrheal

Multi-symptom relief of:
• Nausea    • Heartburn    • Indigestion
• Upset stomach
• Diarrhea

30
CHEWABLE TABLETS

Compare to Pepto-Bismol® active ingredientǂǂ

ǂWalgreens Pharmacist Survey Study, November 2010.
ǂǂThis product is not manufactured or distributed by Procter & Gamble,owner of the registered trademark Pepto-Bismol®.
50844    ORG031231901

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

Soothe
Walgreens 44-319

Soothe

BISMUTH SUBSALICYLATE TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0363-0319
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Bismuth Subsalicylate BISMUTH CATION 262 mg

Inactive Ingredients

Ingredient Name Strength
CALCIUM CARBONATE
D&C RED NO. 27
D&C RED NO. 30
FD&C RED NO. 40
MAGNESIUM STEARATE
mannitol
POVIDONES
STEARIC ACID
talc

Product Characteristics

Color Size Imprint Code Shape
PINK 16 mm 44;319 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BLISTER PACK
2 NDC:0363-0319-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part335 1998-07-16


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Be sure to consult your doctor before taking any medication!
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