Polyethylene Glycol 3350 Powder, For Solution
FDA Label NDC 84386-125

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurobindo Pharma Limited for the product Polyethylene Glycol 3350 (NDC 84386-125). 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 g (cap filled to 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
  • 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

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:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/16/2014


Package Label-Principal Display Panel - 119 G Bottle Label

AUROBINDO

NDC 84386-125-08

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)


     

Package Label-Principal Display Panel - 17 G Sachet Label

Compare to active ingredient
of MiraLax®*

 Polyethylene Glycol 3350
Powder for Oral Solution

Osmotic Laxative

 

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool
  • Sugar Free
  • Dissolves in any Beverage

    • UNFLAVORED POWDER - GRIT FREE

    1 DOSE

    NET WT 0.5 oz (17 g)

    Fig (Polyethylene Fig2)

    Fig (Polyethylene Fig2)


Package Label-Principal Display Panel - 17 G Sachet Carton Label

AUROBINDO

NDC 84386-125-14

Compare to active ingredient
of MiraLax®*

 Polyethylene Glycol 3350
Powder for Oral Solution

Osmotic Laxative

Polyethylene Glycol 3350 powder for
oral solution increases frequency of
bowel movements and softness the stool.

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool
  • Sugar Free
  • Dissolves in Any Beverage

    • 14 ONCE-DAILY DOSES

    UNFLAVORED POWDER - GRIT FREE

    14 PRE-MEASURED, SINGLE DOSES

    14 Packets
    NET WT 0.5 oz
    (17 g Each)

    Package Label-principal Display Panel (17 g Sachet Label)

    Package Label-principal Display Panel (17 g Sachet Label)


* Please review the disclaimer below.