MAJOR BISMUTH SUBSALICYLATE- bismuth subsalicylate tablet, chewable 
Preferred Pharmaceuticals Inc.

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Major Bismuth Subsalicylate

ACTIVE INGREDIENT(in each tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

PURPOSE

Upset stomach reliever and anti-diarrheal

USE(S)

relieves:

diarrhea
heartburn
indigestion
nausea
upset stomach associated with these symptoms

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 behaviour 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 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 DOCTOR IF

symptoms get worse
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) immediately.

DIRECTIONS

chew or dissolve in mouth
adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
do not take more than 8 doses (16 tablets) in 24 hours
children under 12 years: ask a doctor
drink plenty of clear fluids to help prevent dehydration caused diarrhea

OTHER INFORMATION

each tablet contains:
sodium less than 1 mg
salicylate 102 mg
very low sodium
avoid excessive heat (over 104oF or 40oC)
TAMPER EVIDENT: Do not use if individual compartments are torn on open. 

Preferred Pharmaceuticals Inc.

INACTIVE INGREDIENTS

calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium

PRINCIPAL DISPLAY PANEL

MAJOR

NDC 68788-8239-3
*Compare to the active ingredient in Pepto-Bismol®

Bismuth Subsalicylate 262 mg

Upset Stomach Reliever / Anti-diarrheal

Soothing, coating action provides fast relief for

heartburn, indigestion

nausea, upset stomach

and diarrhea



Relabeled By: Preferred Pharmaceuticals Inc.

30 Chewable Tablets

Schematic, timeline

Description automatically generated with medium confidence
MAJOR BISMUTH SUBSALICYLATE 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8239(NDC:0904-7205)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
STARCH, CORN (UNII: O8232NY3SJ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize16mm
FlavorImprint Code G122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-8239-35 in 1 BOX04/06/2023
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug33504/06/2023
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8239)

Revised: 3/2024
Document Id: 9f095986-0c67-4238-9d04-cff2e1adad7e
Set id: 69b9999f-c2e5-43a6-891f-0e24d3c343a4
Version: 2
Effective Time: 20240311
 
Preferred Pharmaceuticals Inc.