gentle lax

gentle lax is an FDA-registered drug product whose active ingredient is POLYETHYLENE GLYCOL 3350. It is labelled by Kroger Company taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 30142-306, application ANDA090685, label effective 20260901. 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.

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.

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

Directions • do not take more than directed unless advised by your doctor • The bottle top is a measuring cup 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 • 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 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).

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.

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

Who makes gentle lax?
Kroger Company is the labeler of record for gentle lax. 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 gentle lax 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 gentle lax 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 gentle lax been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.