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NDC 68788-8128-03 Bismuth Subsalicylate 262 mg 262 mg/1 Details

Bismuth Subsalicylate 262 mg 262 mg/1

Bismuth Subsalicylate 262 mg is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. 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: 68788-8128-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	68788-8128
Product ID	68788-8128_a8f6bd6f-e972-434e-b0de-ab65b67a1ce4
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Bismuth Subsalicylate 262 mg
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	Preferred Pharmaceuticals Inc.
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 68788-8128-03 (68788812803)

Pricing Information	N/A
NDC Package Code	68788-8128-3
Billing NDC	68788812803
Package	30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (68788-8128-3)
Marketing Start Date	2022-02-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a8f6bd6f-e972-434e-b0de-ab65b67a1ce4 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purposes

Anti-diarrheal / Upset stomach reliever

Uses

•: controls diarrhea
•: relieves upset stomach due to overindulgence in food or drink

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.

SPL UNCLASSIFIED SECTION

Allergy alert: Contains salicylates. Do not take if you are:

•: allergic to salicylates (including aspirin)
•: taking other salicylate products

SPL UNCLASSIFIED SECTION

Do not use

•: if you have bloody or black stool
•: if you have an ulcer or bleeding problem

Drug Facts continued on back of label

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have

•: fever
•: mucus in the stool

SPL UNCLASSIFIED SECTION

Ask a doctor or pharmacist before use if you are taking any drug for

•: anticoagulation (thinning the blood)
•: diabetes
•: gout
•: arthritis

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When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

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Stop use and ask a doctor if

•: symptoms get worse or last more than 2 days
•: ringing in the ears or loss of hearing occurs
•: diarrhea lasts more than 2 days

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If pregnant or breast-feeding, ask a health professional before use.

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Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

•: drink plenty of clear fluids to help prevent dehydration caused by diarrhea
•: repeat dosage every 1/2 to 1 hour as needed
•: do not take more than 8 doses in 24 hours
•: use until diarrhea stops but not more than 2 days
•: adults and children 12 years and over: 2 tablets
•: children under 12 years: ask a doctor

Other information

•: each tablet contains: calcium 77 mg, salicylate 102 mg
•: store at 15°-30°C (59°-86°F)
•: protect from moisture

Inactive ingredients

calcium carbonate, D&C red #27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions or comments?

call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Pepto-Bismol®

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

Relabeled By: Preferred Pharmaceuticals Inc.

www.reliable1labs.com

PRINCIPAL DISPLAY PANEL

NDC 68788-8128-3

Bismuth Subsalicylate

262 mg

UPSET STOMACH RELIEVER / ANTIDIARRHEAL

30 CHEWABLE TABLETS

*compare to Active Ingredients in Pepto-Bismol®

INGREDIENTS AND APPEARANCE

BISMUTH SUBSALICYLATE 262 MG

bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68788-8128(NDC:69618-029)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
CHERRY (UNII: BUC5I9595W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
D&C RED NO. 27 (UNII: 2LRS185U6K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY	Imprint Code	AP;045
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68788-8128-3	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/03/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	02/03/2022

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-8128)

Revised: 2/2022

Document Id: a8f6bd6f-e972-434e-b0de-ab65b67a1ce4

Set id: a8f6bd6f-e972-434e-b0de-ab65b67a1ce4

Version: 1

Effective Time: 20220203

Search by Drug Name or NDC

NDC 68788-8128-03 Bismuth Subsalicylate 262 mg 262 mg/1 Details

Bismuth Subsalicylate 262 mg 262 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 68788-8128-03 (68788812803)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a8f6bd6f-e972-434e-b0de-ab65b67a1ce4 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Purposes

Uses

Warnings

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Directions

Other information

Inactive ingredients

Questions or comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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