Polyethylene Glycol 3350 Powder, For Solution
FDA Label NDC 63739-760

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sky Packaging for the product Polyethylene Glycol 3350 (NDC 63739-760). 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, use, allergy alert:, 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 USP, 17g

Purpose

Osmotic Laxative

Use

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

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.

Directions

  • do not take more than directed unless advised by your doctor
  • adults and children 17 years of age and older:
    • use once a day
    • stir and dissolve one packet of powder (17 g) 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

Other Information

  • store at 20° to 25°C (68° to 77°F)
  • tamper-evident: do not use if printed foil pouch is open or broken

Inactive Ingredients

None

Questions Or Comments?

1-888-243-4363

Other

Packaged by:
Novitium Pharma LLC
East Windsor, NJ 08520

Distributed by:
McKesson Corporation dba SKY Packaging
Memphis, TN 38141

Issued: 05/2024

LB4717-00

Principal Display Panel

NDC 63739-760-03
Polyethylene Glycol 3350
Powder for Solution,
Osmotic Laxative

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

    • Dissolves in any Beverage
    Sugar free

    30 Once-Daily Doses
    30 Packets NET WT 0.5 oz (17 g) Each

    30 Single Doses

    Compare to MiraLAX ®Active Ingredient

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