Drugplain

Polyethylene Glycol 3350, NF Powder for Solution, Laxative 17 g/d

Polyethylene Glycol 3350, NF Powder for Solution, Laxative · POWDER, FOR SOLUTION · Pharmaceutica North America, Inc.

No Recall History
Plain English

Polyethylene Glycol 3350, NF Powder for Solution, Laxative is a powder, for solution containing polyethylene glycol 3350, nf powder for solution, laxative at 17 g/d, taken oral. Manufactured by Pharmaceutica North America, Inc..

Key Facts

Brand Name
Polyethylene Glycol 3350, NF Powder for Solution, Laxative
Generic Name
Polyethylene Glycol 3350, NF Powder for Solution, Laxative
NDC Code (Product)
45861-083
Manufacturer
Pharmaceutica North America, Inc.
Strength
17 g/d
Dosage Form
POWDER, FOR SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA090812
Drug Class
Osmotic Laxative [EPC]
Marketing Start
02/10/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

anxiety2 reports
abdominal distension1 reports
abdominal pain upper1 reports
abdominal tenderness1 reports
abnormal behaviour1 reports
aggression1 reports
anal incontinence1 reports
anger1 reports
attention deficit/hyperactivity disorder1 reports
depression1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions d o 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 the 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 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)

Frequently Asked Questions

What is Polyethylene Glycol 3350, NF Powder for Solution, Laxative used for?

Polyethylene Glycol 3350, NF Powder for Solution, Laxative contains Polyethylene Glycol 3350, NF Powder for Solution, Laxative. It is a powder, for solution taken oral. Consult your doctor for specific uses.

Is Polyethylene Glycol 3350, NF Powder for Solution, Laxative a controlled substance?

Polyethylene Glycol 3350, NF Powder for Solution, Laxative is not classified as a controlled substance by the DEA.

What is the generic name for Polyethylene Glycol 3350, NF Powder for Solution, Laxative?

The generic name for Polyethylene Glycol 3350, NF Powder for Solution, Laxative is Polyethylene Glycol 3350, NF Powder for Solution, Laxative. There are no other listed brand versions of Polyethylene Glycol 3350, NF Powder for Solution, Laxative.

What is the NDC code for Polyethylene Glycol 3350, NF Powder for Solution, Laxative 17 g/d?

The NDC (National Drug Code) for Polyethylene Glycol 3350, NF Powder for Solution, Laxative 17 g/d is 45861-083, listed by Pharmaceutica North America, Inc..

Product NDC

45861-083

Package NDC

45861-083-05

Other Polyethylene Glycol 3350, NF Powder for Solution, Laxative Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)