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NDC 48433-0127-10 Bismuth 262 mg/1 Details

Bismuth 262 mg/1

Bismuth is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Safecor Health, LLC. 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: 48433-0127-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	48433-0127
Product ID	48433-127_2b96078c-0b5d-48a7-bbc3-19209568a118
Associated GPIs
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	Bismuth
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bismuth subsalicylate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	262
Active Ingredient Units	mg/1
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	Safecor Health, LLC
Pharmaceutical Class	Bismuth [CS], Bismuth [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part335
Listing Certified Through	2024-12-31

Package

Package Images

NDC 48433-0127-10 (48433012710)

Pricing Information	N/A
NDC Package Code	48433-127-10
Billing NDC	48433012710
Package	100 BLISTER PACK in 1 BOX, UNIT-DOSE (48433-127-10) / 1 TABLET in 1 BLISTER PACK (48433-127-01)
Marketing Start Date	2020-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ba4d807b-4c9b-48ba-a8ea-1f6358a825d7 Details

Active ingredient

Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)

Purpose

Antidiarrheal/Antacid

Uses

relieves
travelers’ diarrhea
diarrhea
upset stomach due to overindulgence in food and drink including:
heartburn
indigestion
nausea
gas
belching
fullness

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

an ulcer
a bleeding problem
bloody or black stool

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 the blood)
diabetes
gout
arthritis

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

When using this product

a temporary, but harmless, darkening of the stool and/or tongue may occur

If pregnant or breast-feeding

ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Directions

Chew or dissolve in mouth
Adults and children 12 years and over : 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
2 tablets (1 dose) every ½ hour as needed for overindulgence
(upset stomach, heartburn, indigestion, nausea)
Do not exceed 8 doses (16 tablets) in 24 hours
Use until diarrhea stops but no more than 2 days
Children under 12 years of age: ask a doctor
Drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other Information

Phenylketonurics: contains phenylalanine 1.1 mg per tablet

Calcium content per tablet: ·73 mg

• save carton for full directions and warnings

• store at room temperature 15°- 30°C (59°- 86°F)

Inactive Ingredients

acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

BISMUTH SUBSALICYLATE

262 mg Chewable Tablet

Contains 100 Unit Dose Blisters NDC: 48433-127-01

3 48433 127 10 0

GTIN: 00348433127100

SN: 222202401

Exp: 2024-03-27

Lot: 22A0078

These unit dose packages meet USP specifications for light resistance.

The package design is not child resistant. For institutional use only.

Distributed by Safecor Health, LLC 317 New Boston St, Woburn MA 01801

06/2022 PN5728

Package/Label Principal Display Panel

Bismuth Subsalicylate

262 mg

Chewable Tablet

Mfg: Allegiant Health

Exp:02/03/24

Lot22A0016

PKG BY: Safecor Health

Woburn, MA

4843312701

INGREDIENTS AND APPEARANCE

BISMUTH

bismuth subsalicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48433-127(NDC:69168-046)
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
ASPARTAME (UNII: Z0H242BBR1)
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTRATES (UNII: G263MI44RU)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ACACIA (UNII: 5C5403N26O)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PEPPERMINT (UNII: V95R5KMY2B)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	17mm
Flavor	PEPPERMINT	Imprint Code	RH046
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:48433-127-10	100 in 1 BOX, UNIT-DOSE	08/01/2020
1	NDC:48433-127-01	1 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	08/01/2020

Labeler - Safecor Health, LLC (828269675)

Name	Address	ID/FEI	Business Operations
Establishment
Safecor Health, LLC		828269675	repack(48433-127)

Name	Address	ID/FEI	Business Operations
Establishment
Allegiant Health		079501930	manufacture(48433-127)

Revised: 6/2022

Document Id: 2b96078c-0b5d-48a7-bbc3-19209568a118

Set id: ba4d807b-4c9b-48ba-a8ea-1f6358a825d7

Version: 2

Effective Time: 20220611