FDA Label for Polyethylene Glycol 3350

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 - polyethylene fig1


 

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

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 - polyethylene fig3