Polyethelene Glycol 3350 Powder For Oralsolution

Polyethelene Glycol 3350 Powder For Oralsolution
SPL v2
SPL
SPL Set ID 3729a1d2-4c98-dfdf-e063-6394a90a5a87
Route
ORAL
Published
Effective Date 2025-06-09
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 2025-06-09
Description

Drug Facts

Purpose

Osmotic Laxative

Medication Information

Purpose

Osmotic Laxative

Description

Drug Facts

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 42229-5
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL POUCH IS OPEN OR BROKEN

*This product is not manufactured by Bay HealthCare LLC, owner of the registered trademark MiraLAX ®

Distributed by:

Kesin Pharma

Oldsmar, FL 34677

Section 50565-1

Keep out of the reach of children.

Directions
  • do not take more than directed unless advised by your doctor
  • adults and children 17 yearsof age and older:
  • use once a day
  • stir and dissolve one packet of powder (17 g) in any 4 to 8 ounce of beverage (cold, hot or room temperature) then drink
  • do not combine with starch-based thickners 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
Do Not Use

if you have kidney disease, except under the advice and supervision of a doctor

Allergy Alert:

Do not use if you are allergic to polyethylene glycol

Other Information
  • store at 20°C to 25°C (68°F to 77°F)
  • tamper-evident: do not use if printed foil pouch is open or broken
  • this package is not child-resistant
Inactive Ingredients

none

Questions Or Comments?

Call 1-833-537-4679

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 need to use a laxative for longer than 1 week
  • you get diarrhea
If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Dose)

Polyethlene Glycol 3350, 17 g

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

NDC 81033-762-14

Polyethylene Glycol 3350 Powder for Oral Solution

Osmotic Laxative

14 Packets

(14 once-daily-doses)

Ask A Doctor Or Pharmacist Before Use If You Are Taking

a prescription drug

Polyethylene Glycol 3350 Increases Frequency of Bowel Movements and Softens Stools

Drug Facts

Structured Label Content

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 42229-5 (42229-5)
TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL POUCH IS OPEN OR BROKEN

*This product is not manufactured by Bay HealthCare LLC, owner of the registered trademark MiraLAX ®

Distributed by:

Kesin Pharma

Oldsmar, FL 34677

Section 50565-1 (50565-1)

Keep out of the reach of children.

Purpose

Osmotic Laxative

Directions
  • do not take more than directed unless advised by your doctor
  • adults and children 17 yearsof age and older:
  • use once a day
  • stir and dissolve one packet of powder (17 g) in any 4 to 8 ounce of beverage (cold, hot or room temperature) then drink
  • do not combine with starch-based thickners 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
Do Not Use (Do not use)

if you have kidney disease, except under the advice and supervision of a doctor

Allergy Alert: (Allergy alert:)

Do not use if you are allergic to polyethylene glycol

Other Information (Other information)
  • store at 20°C to 25°C (68°F to 77°F)
  • tamper-evident: do not use if printed foil pouch is open or broken
  • this package is not child-resistant
Inactive Ingredients (Inactive ingredients)

none

Questions Or Comments? (Questions or comments?)

Call 1-833-537-4679

When Using This Product (When using this product)

you may have loose, watery, more frequent stools

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 need to use a laxative for longer than 1 week
  • you get diarrhea
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Dose) (Active ingredient (in each dose))

Polyethlene Glycol 3350, 17 g

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 (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 81033-762-14

Polyethylene Glycol 3350 Powder for Oral Solution

Osmotic Laxative

14 Packets

(14 once-daily-doses)

Ask A Doctor Or Pharmacist Before Use If You Are Taking (Ask a doctor or pharmacist before use if you are taking)

a prescription drug

Polyethylene Glycol 3350 Increases Frequency of Bowel Movements and Softens Stools (Polyethylene Glycol 3350 increases frequency of bowel movements and softens stools)

Drug Facts

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:17.867832 · Updated: 2026-03-14T23:08:59.288880