Polyethelene Glycol 3350, Powder For Solution

Polyethelene Glycol 3350, Powder For Solution
SPL v2
SPL
SPL Set ID 5aba6bb1-d25d-4901-8e9c-4cd4a3a06471
Route
ORAL
Published
Effective Date 2026-01-27
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 2024-09-19

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 50565-1

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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.

Allergy Alert:

Do not use if you are allergic to polyethylene glycol

Other Information
  • store at 20° - 25°C (68° - 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

Directions (can Only)
  • 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:
    • o
      use once a day
    • o
      fill to top of white section in cap which is marked to indicate the correct dose (17 g)
    • o
      stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • o
      do not combine with starch-based thickeners used for difficulty swallowing
    • o
      ensure that the powder is fully dissolved before drinking
    • o
      do not drink if there are any clumps
    • o
      do not use more than 7 days
  • children 16 years of age or under: ask a doctor
Questions Or Comments?

Call weekdays 9 AM to 5 PM at 1 (888) 721-7115.

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

Distributed by

Glenmark Therapeutics Inc., USA

Elmwood Park, NJ 07407

Directions (packet Only)
  • do not take more than directed unless advised by your doctor
  • adults and children 17 years of age and older:
    • o
      use once a day
    • o
      stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • o
      do not combine with starch-based thickeners used for difficulty swallowing
    • o
      ensure that the powder is fully dissolved before drinking
    • o
      do not drink if there are any clumps
    • o
      do not use more than 7 days
  • children 16 years of age or under: ask a doctor
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
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 72657-196-16 Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool
  • TAMPER-EVIDENT: do not use if printed foil seal under cap is missing, open or broken
  • Unflavored
  • Sugar Free
  • Dissolves in Any Beverage

45 ONCE-DAILY DOSES

NET WT 26.9 OZ (765 g) EACH

45s Label front

45s Label back
Active Ingredient (in Each Dose) (can Only)

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

Polyethylene Glycol 3350, Powder for Solution

Drug Facts

Active Ingredient (in Each Dose) (packet Only)

Polyethylene Glycol 3350, 17 g


Structured Label Content

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Section 50565-1 (50565-1)

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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

Allergy Alert: (Allergy alert:)

Do not use if you are allergic to polyethylene glycol

Other Information
  • store at 20° - 25°C (68° - 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

Directions (can Only) (Directions (Can Only))
  • 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:
    • o
      use once a day
    • o
      fill to top of white section in cap which is marked to indicate the correct dose (17 g)
    • o
      stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • o
      do not combine with starch-based thickeners used for difficulty swallowing
    • o
      ensure that the powder is fully dissolved before drinking
    • o
      do not drink if there are any clumps
    • o
      do not use more than 7 days
  • children 16 years of age or under: ask a doctor
Questions Or Comments? (Questions or comments?)

Call weekdays 9 AM to 5 PM at 1 (888) 721-7115.

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

Distributed by

Glenmark Therapeutics Inc., USA

Elmwood Park, NJ 07407

Directions (packet Only) (Directions (Packet Only))
  • do not take more than directed unless advised by your doctor
  • adults and children 17 years of age and older:
    • o
      use once a day
    • o
      stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • o
      do not combine with starch-based thickeners used for difficulty swallowing
    • o
      ensure that the powder is fully dissolved before drinking
    • o
      do not drink if there are any clumps
    • o
      do not use more than 7 days
  • children 16 years of age or under: ask a doctor
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
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 72657-196-16 Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool
  • TAMPER-EVIDENT: do not use if printed foil seal under cap is missing, open or broken
  • Unflavored
  • Sugar Free
  • Dissolves in Any Beverage

45 ONCE-DAILY DOSES

NET WT 26.9 OZ (765 g) EACH

45s Label front

45s Label back
Active Ingredient (in Each Dose) (can Only) (Active ingredient (in each dose) (Can only))

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

Polyethylene Glycol 3350, Powder for Solution

Drug Facts

Active Ingredient (in Each Dose) (packet Only) (Active ingredient (in each dose) (Packet Only))

Polyethylene Glycol 3350, 17 g


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)