Drugplain

Discount Drug Mart 17 g/17g

Polyethylene Glycol 3350 · POWDER, FOR SOLUTION · DISCOUNT DRUG MART

10 Recalls on Record
Plain English

Polyethylene Glycol 3350 is an osmotic laxative that works by drawing water into the bowel to help relieve constipation. This powder medication is mixed with water and taken by mouth to promote bowel movements.

Key Facts

Brand Name
Discount Drug Mart
Generic Name
Polyethylene Glycol 3350
NDC Code (Product)
53943-652
Manufacturer
DISCOUNT DRUG MART
Strength
17 g/17g
Dosage Form
POWDER, FOR SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA202071
Drug Class
Osmotic Laxative [EPC]
Marketing Start
04/17/2023

Recall History

10 Recalls on Record
Class II02/07/2014

Ohm Laboratories, Inc.

Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.

TerminatedVoluntary: Firm initiated
Class II03/20/2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

OngoingVoluntary: Firm initiated
Class II08/23/2019

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

TerminatedVoluntary: Firm initiated
Class III07/28/2015

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

TerminatedVoluntary: Firm initiated
Class II02/20/2019

Vi-Jon, Inc.

Cross Contamination: Presence of IPA in finished product.

TerminatedVoluntary: Firm initiated
Class II07/15/2022

Vi-Jon, LLC

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II03/20/2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

OngoingVoluntary: Firm initiated
Class II03/03/2026

K.C. Pharmaceuticals, Inc

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II03/03/2026

K.C. Pharmaceuticals, Inc

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class III02/14/2020

AAA Pharmaceutical, Inc.

Labeling: Incorrect or Missing Lot and/or Expiration date.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use13,019 reports
drug ineffective12,983 reports
fatigue9,569 reports
nausea8,964 reports
pain8,096 reports
headache7,771 reports
diarrhoea7,352 reports
dyspnoea6,919 reports
condition aggravated6,616 reports
rash6,517 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use temporary relieves: ■ cough due to cold ■ occasional minor irritation or sore throat

Dosage & Administration

Directions ■ adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed. ■ children under 5 years: ask a doctor.

Warnings

Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.

Frequently Asked Questions

What is Discount Drug Mart used for?

Polyethylene Glycol 3350 is an osmotic laxative that works by drawing water into the bowel to help relieve constipation. This powder medication is mixed with water and taken by mouth to promote bowel movements.

Is Discount Drug Mart a controlled substance?

Discount Drug Mart is not classified as a controlled substance by the DEA.

What is the generic name for Discount Drug Mart?

The generic name for Discount Drug Mart is Polyethylene Glycol 3350. There are 12 other brand versions of Polyethylene Glycol 3350.

What is the NDC code for Discount Drug Mart 17 g/17g?

The NDC (National Drug Code) for Discount Drug Mart 17 g/17g is 53943-652, listed by DISCOUNT DRUG MART.