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NDC 00904-1315-46 Bismatrol 262 mg/1 Details

Bismatrol 262 mg/1

Bismatrol is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is BISMUTH SUBSALICYLATE.

MedlinePlus Drug Summary

Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.

Related Packages: 00904-1315-46
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	00904-1315
Product ID	0904-1315_055c5066-0e1f-4724-af9a-c2ff0a035ea1
Associated GPIs	47300010000507
GCN Sequence Number	002860
GCN Sequence Number Description	bismuth subsalicylate TAB CHEW 262 MG ORAL
HIC3	D6D
HIC3 Description	ANTIDIARRHEALS
GCN	08420
HICL Sequence Number	001246
HICL Sequence Number Description	BISMUTH SUBSALICYLATE
Brand/Generic	Generic
Proprietary Name	Bismatrol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bismuth subsalicylate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	262
Active Ingredient Units	mg/1
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	Major Pharmaceuticals
Pharmaceutical Class	Bismuth [CS], Bismuth [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part335
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00904-1315-46 (00904131546)

Pricing Information
NDC Package Code	0904-1315-46
Billing NDC	00904131546
Package	5 BLISTER PACK in 1 CARTON (0904-1315-46) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	2003-01-03
NDC Exclude Flag	N
Price Per Unit	0.0759
Pricing Unit	EA
Effective Date	2022-11-23
NDC Description	BISMATROL TABLET CHEW
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL e5021687-11aa-472a-bd06-151415e1e2b3 Details

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

Purpose

Upset stomach reliever and anti-diarrheal

SPL UNCLASSIFIED SECTION

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.

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 0904-1315-46

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

INGREDIENTS AND APPEARANCE

BISMATROL

bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-1315
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	262 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	pink	Score	no score
Shape	ROUND	Size	17mm
Flavor		Imprint Code	GDC122
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-1315-46	5 in 1 CARTON	01/03/2003
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	01/03/2003

Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2022

Document Id: 055c5066-0e1f-4724-af9a-c2ff0a035ea1

Set id: e5021687-11aa-472a-bd06-151415e1e2b3

Version: 6

Effective Time: 20220119