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Bismatrol by Proficient Rx LP

Dosage form: tablet, chewable
Ingredients: BISMUTH SUBSALICYLATE 262mg
Labeler: Proficient Rx LP
NDC Code: 63187-650

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.

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

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 which may accompany diarrhea.

Other information: each tablet contains:

sodium less than 1 mg
salicylate 102 mg
calcium 140 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 and C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.

Principal Display Panel

MAJOR

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

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®

30 chewable tablets

BISMATROL 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-650(NDC:0904-1315)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (BISMUTH CATION) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
D&C RED NO. 27 
MAGNESIUM STEARATE 
MANNITOL 
STARCH, CORN 
SACCHARIN SODIUM 
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize17mm
FlavorImprint CodeGDC122
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-650-305 BLISTER PACK in 1 CARTON
16 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33501/03/2003
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574RELABEL(63187-650)

Revised: 02/2016
 
Proficient Rx LP

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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