good sense clearlax

POLYETHYLENE GLYCOL 3350 ORAL HUMAN OTC DRUG

good sense clearlax is an FDA drug label for the active ingredient POLYETHYLENE GLYCOL 3350 manufactured by L. Perrigo Company administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230601.

Generic name
POLYETHYLENE GLYCOL 3350
Manufacturer
L. Perrigo Company
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
0113-1023
Application
ANDA090685
Label effective
20230601

About this product

good sense clearlax is an FDA-registered drug product whose active ingredient is POLYETHYLENE GLYCOL 3350. It is labelled by L. Perrigo Company taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0113-1023, application ANDA090685, label effective 20230601. It is one of 45 FDA drug label records sharing the active ingredient POLYETHYLENE GLYCOL 3350. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing POLYETHYLENE GLYCOL 3350 are most often described in connection with: relieves occasional, constipation irregularity, generally produces, bowel movement. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient (in each dose) Polyethylene Glycol 3350, 17 g (cap filled to line)

Indications & Usage

Use • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days

Dosage & Administration

Directions • do not take more than directed unless advised by your doctor • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap) • adults and children 17 years of age and older: • use once a day • fill to top of white section in cap which is marked to indicate the correct dose (17 g) • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink • do not combine with starch-based thickeners used for difficulty swallowing • ensure that the powder is fully dissolved before drinking • do not drink if there are any clumps • do not use more than 7 days • children 16 years of age or under: ask a doctor

Warnings

Warnings Allergy alert: Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have • nausea, vomiting or abdominal pain • a sudden change in bowel habits that lasts over 2 weeks • irritable bowel syndrome Ask a doctor or pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools Stop use and ask a doctor if • you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition. • you get diarrhea • you need to use a laxative for longer than 1 week 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 (1-800-222-1222).

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How products containing POLYETHYLENE GLYCOL 3350 compare

FDA lists 45 drug label records with POLYETHYLENE GLYCOL 3350 as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Amazon.com Services LLC 4
— — L. Perrigo Company 3
— — CVS Pharmacy 2
— — Cardinal Health 107, LLC 2
— — Major Pharmaceuticals 2

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0912-2023 Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007. L. Perrigo Company Class II Terminated 20230719
D-0910-2023 allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN 55403. L. Perrigo Company Class II Terminated 20230719
D-0909-2023 allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811. L. Perrigo Company Class II Terminated 20230719
D-0906-2023 allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. L. Perrigo Company Class II Terminated 20230719
D-0903-2023 Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 69842-0914-39 L. Perrigo Company Class II Terminated 20230719

Frequently asked questions

What is good sense clearlax used for?
Use • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days

Who makes good sense clearlax?
L. Perrigo Company is the labeler of record for good sense clearlax. 45 FDA label records share the active ingredient POLYETHYLENE GLYCOL 3350, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does good sense clearlax come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is good sense clearlax prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing POLYETHYLENE GLYCOL 3350?
Yes. 45 FDA drug label records list POLYETHYLENE GLYCOL 3350 as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has good sense clearlax been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.