365 WHOLE FOODS MARKET Polyethylene Glycol 3350

POLYETHYLENE GLYCOL 3350 ORAL HUMAN OTC DRUG

365 WHOLE FOODS MARKET Polyethylene Glycol 3350 is an FDA drug label for the active ingredient POLYETHYLENE GLYCOL 3350 manufactured by Whole Foods Market, Inc. 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 20260605.

Generic name
POLYETHYLENE GLYCOL 3350
Manufacturer
Whole Foods Market, Inc.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
42681-0059
Application
ANDA209017
Label effective
20260605

About this product

365 WHOLE FOODS MARKET Polyethylene Glycol 3350 is an FDA-registered drug product whose active ingredient is POLYETHYLENE GLYCOL 3350. It is labelled by Whole Foods Market, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 42681-0059, application ANDA209017, label effective 20260605. 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

Drug Facts Active ingredient (in each dose) Polyethylene Glycol 3350, USP 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 (17g) 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

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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

Frequently asked questions

What is 365 WHOLE FOODS MARKET Polyethylene Glycol 3350 used for?
Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days

Who makes 365 WHOLE FOODS MARKET Polyethylene Glycol 3350?
Whole Foods Market, Inc. is the labeler of record for 365 WHOLE FOODS MARKET Polyethylene Glycol 3350. 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 365 WHOLE FOODS MARKET Polyethylene Glycol 3350 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 365 WHOLE FOODS MARKET Polyethylene Glycol 3350 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 365 WHOLE FOODS MARKET Polyethylene Glycol 3350 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.

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.