Drugplain

Walgreens 100 mg/5mL

Childrens Stuffy Nose and Cold · SOLUTION · WALGREENS CO.

10 Recalls on Record
Plain English

Walgreens is a solution containing childrens stuffy nose and cold at 100 mg/5mL, taken oral. Manufactured by WALGREENS CO..

Key Facts

Brand Name
Walgreens
Generic Name
Childrens Stuffy Nose and Cold
NDC Code (Product)
0363-7480
Manufacturer
WALGREENS CO.
Strength
100 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
05/15/2019

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 II08/23/2013

Walgreens Co

Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate sterile injection due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.

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 II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class I07/15/2022

Vi-Jon, LLC

Microbial contamination of non-sterile products.

TerminatedVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class II04/16/2015

Tarmac Products, Inc.

Products failed the Antimicrobial Effectiveness Test

TerminatedVoluntary: Firm initiated
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

Side Effects Reported to FDA

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

off label use23,214 reports
drug ineffective22,556 reports
fatigue20,903 reports
nausea20,080 reports
pain17,431 reports
dyspnoea17,123 reports
diarrhoea16,028 reports
headache15,968 reports
vomiting15,093 reports
pyrexia13,661 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Directions -detach one suppository from the strip -remove wrapper before inserting into the rectum adults and children 12 years of age and older 1 suppository once daily children 6 to under 12 years 1/2 suppository once daily children under 6 years do not use

Dosage & Administration

Directions -detach one suppository from the strip -remove wrapper before inserting into the rectum adults and children 12 years of age and older 1 suppository once daily children 6 to under 12 years 1/2 suppository once daily children under 6 years do not use

Warnings

Warnings For rectal use only.

Frequently Asked Questions

What is Walgreens used for?

Walgreens contains Childrens Stuffy Nose and Cold. It is a solution taken oral. Consult your doctor for specific uses.

Is Walgreens a controlled substance?

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

What is the generic name for Walgreens?

The generic name for Walgreens is Childrens Stuffy Nose and Cold. There are 1 other brand versions of Childrens Stuffy Nose and Cold.

What is the NDC code for Walgreens 100 mg/5mL?

The NDC (National Drug Code) for Walgreens 100 mg/5mL is 0363-7480, listed by WALGREENS CO..

Product NDC

0363-7480

Package NDC

0363-7480-04

Other Childrens Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)