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Name:Bismuth Subsalicylate
Manufacturer:A&z Pharmaceutical, Inc.
Category:Over-the-counter (OTC) Marketed Drugs

Bismuth Subsalicylate 262mg

BISMUTH SUBSALICYLATE  - bismuth subsalicylate tablet, chewable 
A&Z Pharmaceutical, Inc.

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.


Bismuth Subsalicylate 262mg


■ controls diarrhea ■ relives heartburn, indigestion, nausea and upset stomach without constipating


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

Ask a Doctor

before use if you have ■ fever ■ mucus in the stool

Ask a Doctor/Pharmacist before use if you

are taking any drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ arthritis

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

When using this product

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately.


■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea ■ Adults and Children 12 years and over: 525 mg (2 tablets) every 1/2 to 1 hour or 1050mg (4 tablets) every hour as needed ■ do not exceed 4200 mg (16 tablets) in 24 hours ■ use until diarrhea stops but not more than 2 days ■ Children under 12 years: ask a doctor

Other information

■ save carton for full directions and warnings ■ store at room temperature 59°- 86°F (15°-30°C) ■ do not use if cellophane unit is torn ■ Phenylketonurics: contains phenylalanine 1.1 mg per tablet ■ Calcium content per tablet: 73 mg

Inactive ingredients

aspartame, calcium carbonate, D&C red #27, dextrates, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide.


picture of carton

bismuth subsalicylate tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62211-046(NDC:046)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 27  
Product Characteristics
Color pink Score no score
Shape ROUND Size 16mm
Flavor Imprint Code AZ046
# Item Code Package Description Multilevel Packaging
1 NDC:62211-046-69 12 TABLET, CHEWABLE ( TABLET) in 1 CELLO PACK None
2 NDC:62211-046-18 18 TABLET, CHEWABLE ( TABLET) in 1 CELLO PACK None
3 NDC:62211-046-88 30 TABLET, CHEWABLE ( TABLET) in 1 CELLO PACK None
4 NDC:62211-046-99 15000 TABLET, CHEWABLE ( TABLET) in 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part335 03/10/2003

Labeler - A&Z Pharmaceutical, Inc. (926820705)
Registrant - A&Z Pharmaceutical, Inc. (926820705)

Revised: 04/2010 A&Z Pharmaceutical, Inc.

Reproduced with permission of U.S. National Library of Medicine

Copyright © 2020 by Dionisios Fentas || Terms of Use


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