BISMATROL- bismuth subsalicylate tablet, chewable 
Preferred Pharmaceuticals 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.

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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 CARTON04/19/2018
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 finalpart33504/19/2018
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7140)

Revised: 4/2023
Document Id: e09b08be-8e27-4f7c-947f-bfc3fa1ca8c6
Set id: e1d5e365-5dc8-4d77-a730-f59eeb8fb01a
Version: 6
Effective Time: 20230406
 
Preferred Pharmaceuticals Inc.