Polyethylene Glycol 3350 Powder For Oral Solution

Polyethylene Glycol 3350 Powder For Oral Solution
SPL v8
SPL
SPL Set ID d3c77f3f-57aa-4e2d-88aa-731cbb22af70
Route
ORAL
Published
Effective Date 2025-09-11
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 3350 (17 g)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2018-04-09

Description

Active ingredient (in each dose) Polyethylene Glycol 3350, USP 17 g (cap filled to line)

Purpose

Osmotic Laxative


Medication Information

Purpose

Osmotic Laxative

Description

Active ingredient (in each dose) Polyethylene Glycol 3350, USP 17 g (cap filled to line)

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Section 50567-7

When using this product you may have loose, watery, more frequent stools

Section 50568-5

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

Section 50570-1

Do not use if you have kidney disease, except under the advice and supervision of a doctor

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

Allergy alert: Do not use if you are allergic to polyethylene glycol

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
Drug Facts

Active ingredient (in each dose)



Polyethylene Glycol 3350, USP 17 g (cap filled to line)

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/16/2014



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
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.

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
Package Label Principal Display Panel 17 G Sachet Label

AUROHEALTH



NDC 58602-805-26



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)





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 17 G Sachet Carton label

AUROHEALTH



NDC 58602-805-27



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






Structured Label Content

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Section 50567-7 (50567-7)

When using this product you may have loose, watery, more frequent stools

Section 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

Do not use if you have kidney disease, except under the advice and supervision of a doctor

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Osmotic Laxative

Warnings

Allergy alert: Do not use if you are allergic to polyethylene glycol

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
Drug Facts

Active ingredient (in each dose)



Polyethylene Glycol 3350, USP 17 g (cap filled to line)

Other Information (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 (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/16/2014



Stop Use and Ask A Doctor If (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
Keep Out of Reach of Children. (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.

Ask A Doctor Before Use If You Have (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
Package Label Principal Display Panel 17 G Sachet Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Sachet Label)

AUROHEALTH



NDC 58602-805-26



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)





Package Label Principal Display Panel 119 G Bottle Label (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 17 G Sachet Carton label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Sachet Carton Label)

AUROHEALTH



NDC 58602-805-27



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






Advanced Ingredient Data


Raw Label Data

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