WALGREEN- bismuth subsalicylate tablet, film coated

Walgreen by

Drug Labeling and Warnings

Walgreen by is a Otc medication manufactured, distributed, or labeled by WALGREEN CO.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each caplets)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever/anti-diarrheal

Uses

Relieves:

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

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.

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Allergy alert: Contains salicylates. Do not take if you are:

• ▪ allergic to salicylates (including aspirin)
• ▪ taking other salicylate products

DO NOT USE

Do not use if you have

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

ASK DOCTOR

Ask a doctor before use if you have

• ▪ fever
• ▪ mucus in the stool

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking any drug for

• ▪ anticoagulation (thinning the blood)
• ▪ diabetes
• ▪ gout
• ▪ arthritis

WHEN USING

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

STOP USE

Stop use and ask a doctor if

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

• ▪ swallow with water; do not chew
• ▪ adults and children 12 years and over: 2 caplets 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
• ▪ drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

• ▪ each tablet contains: calcium 27 mg, sodium 3 mg
• ▪ salicylate 99 mg
• ▪ low sodium
• ▪ sugar free
• ▪ store at room temperature

Inactive ingredients

calcium carbonate, crospovidone, D&C red # 27 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium lauryl sulfate.

Questions or comments?

Call 1-866-467-2748

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TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

PRINCIPAL DISPLAY PANEL

NDC: 0363-9125-40

Compare to Pepto-Bismol® active ingredient††

Soothe®

BISMUTH SUBSALICYLATE, 262 mg/

UPSET STOMACH RELIEVER / ANTI-DIARRHEAL

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

40 CAPLETS.

†† Walgreens Pharmacist Survey

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

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INGREDIENTS AND APPEARANCE

WALGREEN 
bismuth subsalicylate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9125
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	RP125
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9125-40	40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	05/14/2019

Labeler - WALGREEN CO. (008965063)