Polyethylene Glycol 3350 Powder, For Solution
FDA Label NDC 58602-805

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Polyethylene Glycol 3350 (NDC 58602-805). 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 drug facts, purpose, use, warnings, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, USP 17 grams (cup filled to the indicated 17 grams line)

Purpose

Osmotic Laxative

Use

  • 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

Otc - Do Not Use

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug

Otc - When Using

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

Otc - Pregnancy Or Breast Feeding

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 (1-800-222-1222) right away.

Directions

  • do not take more than directed unless advised by your doctor
  • this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line
  • adults and children 17 years of age and older:
    • use once a day
    • fill to the indicated 17 grams line on cup which is marked to indicate the correct dose 17 grams
    • 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 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 foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Inactive Ingredients

none

Questions or comments?

call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/19/1993

Package Label-Principal Display Panel - 119 G Bottle Label

AUROHEALTH

NDC 58602-805-01

Compare to active ingredient
of MiraLax®*

Polyethylene Glycol 3350
Powder for Oral Solution

Osmotic Laxative

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

    • UNFLAVORED POWDER - GRIT FREE

    7 ONCE-DAILY DOSES            NET WT 4.1 OZ (119 g)
     

    Package Label-principal Display Panel (119 g Bottle Label)

    Package Label-principal Display Panel (119 g Bottle Label)


     

* Please review the disclaimer below.