Polyethylene Glycol (3350) Powder, For Solution
FDA Label NDC 51079-306

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mylan Institutional Inc. for the product Polyethylene Glycol (3350) (NDC 51079-306). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each dose), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Dose)

Polyethylene Glycol (3350), NF, 17 g

Purpose

Osmotic Laxative

Uses

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

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 The Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than directed unless advised by your doctor
  • adults and children 17 years of age and older:
    • stir and dissolve the contents of one pouch (17 g) into any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • use once a day
    • use no more than 7 days
    • children 16 years of age or under: ask a doctor

Other Information

  • store at 20° to 25°C (68° to 77°F)
  • tamper-evident: do not use if pouch is damaged or torn
  • keep carton for future reference
  • for institutional use only

Inactive Ingredients

none

Questions Or Comments?

1-877-INFO-RX (1-877-446-3679)

Polyethylene Glycol 3350 Powder for
Solution increases frequency of bowel
movement and softens the stool.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

Principal Display Panel

NDC 51079-306-30

Polyethylene Glycol (3350), NF
Powder for Solution,
Osmotic Laxative

Original Prescription Strength

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool
  • Dissolves in Any Beverage
  • Unflavored
  • POWDER
  • Grit Free

    • Sugar Free

    This carton contains 30 single-dose pouches.
    Each pouch contains 17 grams of
    polyethylene glycol (3350), NF powder.

    For institutional use only.     30 Single-Dose Pouches

    Polyethylene Glycol (3350), Nf Powder For Solution, Osmotic Laxative Carton Label (Image 01)

    Polyethylene Glycol (3350), Nf Powder For Solution, Osmotic Laxative Carton Label (Image 01)

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