BISMATROL- bismuth subsalicylate tablet, chewable 
Preferred Pharmaceuticals Inc.

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Major Bismatrol Chewable Tablets

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

Purpose

Upset stomach reliever and anti-diarrheal

Uses

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 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 stools
•
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 a 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 immediately.

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 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 fluids to help prevent dehydration caused by diarrhea.

Other information:

each tablet contains:

•
sodium less than 1 mg
•
salicylate 102 mg
•
very low sodium
•
avoid excessive heat (over 104˚F or 40˚C)
•
TAMPER EVIDENT:Do not use if individual compartments are torn or missing.

Inactive ingredients

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

Principal Display Panel

MAJOR

NDC 68788-7140-3

Bismatrol Chewable Tablets

Soothing, coating action provides

fast relief for heartburn, indigestion, nausea, upset stomach and diarrhea

COMPARE TO THE ACTIVE INGREDIENT IN PEPTO-BISMOL®

Relabeled By: Preferred Pharmaceuticals Inc.

30 chewable tablets

Bismatrol Chewable Tablets
BISMATROL 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7140(NDC:0904-1315)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) 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
ShapeROUNDSize17mm
FlavorImprint Code GDC122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-7140-35 in 1 CARTON04/19/201804/06/2023
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 Drug33504/19/201804/06/2023
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7140)

Revised: 3/2024
Document Id: 49e3c9c1-9bb3-4d9b-8bc3-08b64d73df6a
Set id: e1d5e365-5dc8-4d77-a730-f59eeb8fb01a
Version: 7
Effective Time: 20240311
 
Preferred Pharmaceuticals Inc.