Drugplain

Walgreen 262 mg/1

Bismuth Subsalicylate · TABLET, CHEWABLE · WALGREEN COMPANY

10 Recalls on Record
Plain English

Walgreen is a tablet, chewable containing bismuth subsalicylate at 262 mg/1, taken oral. Manufactured by WALGREEN COMPANY.

Key Facts

Brand Name
Walgreen
Generic Name
Bismuth Subsalicylate
NDC Code (Product)
0363-9124
Manufacturer
WALGREEN COMPANY
Strength
262 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
Application #
M008
Drug Class
Bismuth [EPC]
Marketing Start
03/05/2019

Recall History

10 Recalls on Record
Class II11/01/2013

L. Perrigo Co.

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

TerminatedVoluntary: Firm initiated
Class II08/23/2019

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

TerminatedVoluntary: Firm initiated
Class III08/03/2018

Product Quest Manufacturing LLC

Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.

TerminatedVoluntary: Firm initiated
Class II06/28/2022

Vi-Jon, LLC

Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.

TerminatedVoluntary: Firm initiated
Class II07/18/2012

LNK International, Inc.

Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.

TerminatedVoluntary: Firm initiated
Class II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

TerminatedVoluntary: Firm initiated
Class II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

TerminatedVoluntary: Firm initiated
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated
Class III07/18/2024

Granules Consumer Health Inc.

Label mix-up: Carton incorrectly labeled.

TerminatedVoluntary: Firm initiated
Class I07/15/2022

Vi-Jon, LLC

Microbial contamination of non-sterile products.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use23,725 reports
fatigue22,027 reports
drug ineffective20,332 reports
pain19,456 reports
nausea19,177 reports
headache18,045 reports
toxicity to various agents16,937 reports
dyspnoea16,029 reports
arthralgia15,272 reports
pyrexia15,097 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Dosage & Administration

Directions do not take more than 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product ml = milliliter this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 ml every 4 hours children under 12 years do not use

Warnings

Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. 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 right away at 1-800-222-1222.

Frequently Asked Questions

What is Walgreen used for?

Walgreen contains Bismuth Subsalicylate. It is a tablet, chewable taken oral. Consult your doctor for specific uses.

Is Walgreen a controlled substance?

Walgreen is not classified as a controlled substance by the DEA.

What is the generic name for Walgreen?

The generic name for Walgreen is Bismuth Subsalicylate. There are 12 other brand versions of Bismuth Subsalicylate.

What is the NDC code for Walgreen 262 mg/1?

The NDC (National Drug Code) for Walgreen 262 mg/1 is 0363-9124, listed by WALGREEN COMPANY.