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Polyethylene Glycol 3350 Powder for Solution

polyethylene glycol, unspecified · Polyethylene Glycol 3350 Powder for Solution is an osmotic laxative (over-the-counter) containing polyethylene glycol, unspecified, made by VALLEY MEDICAL PRODUCTS, LLC.

Type
Over the counter
Drug class
Osmotic Laxative
Route
Topical
Manufacturers
1

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

Drug facts

Generic name
polyethylene glycol, unspecified
Active ingredients
Polyethylene Glycol 3350
How it works
Osmotic Activity
Dosage forms
Powder, for solution
Label holder
VALLEY MEDICAL PRODUCTS, LLC
FDA application
ANDA203928
Label updated
10/27/2025

Active ingredients

(in each dose) Polyethylene Glycol 3350, 17 g (cap filled to line) Purpose Osmotic Laxative

Purpose

Osmotic Laxative

Uses

  • 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 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

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.

Do not use

If you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use

  • 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

Taking a prescription drug

When using this product

You may have loose, watery, more frequent stools

Stop use and ask a doctor

  • 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

Pregnancy or breastfeeding

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.

Inactive ingredients

None

Questions?

1-800-403-9832

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Powder, for solution17 g/17gtopical1

Manufacturers and labels

1 FDA label

  • VALLEY MEDICAL PRODUCTS, LLCShown hereANDA203928 · Label 10/27/2025 · NDC 76470-069Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Polyethylene Glycol 3350 Powder for Solution: common questions

What is Polyethylene Glycol 3350 Powder for Solution used for?
• relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days
Is Polyethylene Glycol 3350 Powder for Solution a prescription drug?
No. Polyethylene Glycol 3350 Powder for Solution is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Polyethylene Glycol 3350 Powder for Solution?
Yes. Other FDA-listed products with the same active ingredients include Clearlax, Polyethylene Glycol 3350, Nf Powder for Solution, Laxative, clear lax, dg health clearlax.
Who makes Polyethylene Glycol 3350 Powder for Solution?
VALLEY MEDICAL PRODUCTS, LLC lists Polyethylene Glycol 3350 Powder for Solution with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 10/27/2025 · Label text is shown as published by the manufacturer. Not medical advice