Drug Facts

Drug Facts
SPL v15
SPL
SPL Set ID 219bcbc4-b84a-4209-9f34-ef2b0ef0d273
Route
ORAL
Published
Effective Date 2023-10-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 3500 (17 g)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2009-10-12
Description

Polyethylene Glycol 3350, USP, 17 g

Purpose

Osmotic Laxative

Medication Information

Purpose

Osmotic Laxative

Description

Polyethylene Glycol 3350, USP, 17 g

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

Directions
  • do not take more than directed unless advised by your doctor
  • adults and children 17 years of age and older:
    • use once a day
    • stir and dissolve the contents of one pouch (17 g) 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 no 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

Other Information
  • store at 20° to 25°C (68° to 77°F)
  • tamper-evident: do not use if pouch is damaged or torn
  • for institutional use only
Inactive Ingredients

none

Questions Or Comments?

1-877-4-INFO-RX (1-877-446-3679)

Manufactured for:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

MII306-30:R8

Principal Display Panel

NDC 51079-306-30

Polyethylene Glycol 3350, USP

Powder for Solution,

Osmotic Laxative

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

 

  • Unflavored
  • Powder
  • Grit Free
  • Sugar Free
  • Dissolves in Any Beverage

This carton contains 30 single-dose pouches.

Each pouch contains 17 grams of

polyethylene glycol 3350, USP powder.

For institutional use only.     30 Single-Dose Pouches

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
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 right away.

Active Ingredient (in Each Dose)

Polyethylene Glycol 3350, USP, 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
Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug

Structured Label Content

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
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
  • adults and children 17 years of age and older:
    • use once a day
    • stir and dissolve the contents of one pouch (17 g) 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 no 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

Other Information
  • store at 20° to 25°C (68° to 77°F)
  • tamper-evident: do not use if pouch is damaged or torn
  • for institutional use only
Inactive Ingredients (Inactive ingredients)

none

Questions Or Comments? (Questions or comments?)

1-877-4-INFO-RX (1-877-446-3679)

Manufactured for:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

MII306-30:R8

Principal Display Panel

NDC 51079-306-30

Polyethylene Glycol 3350, USP

Powder for Solution,

Osmotic Laxative

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

 

  • Unflavored
  • Powder
  • Grit Free
  • Sugar Free
  • Dissolves in Any Beverage

This carton contains 30 single-dose pouches.

Each pouch contains 17 grams of

polyethylene glycol 3350, USP powder.

For institutional use only.     30 Single-Dose Pouches

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

ask a health professional before use.

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 right away.

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

Polyethylene Glycol 3350, USP, 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
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:18.034613 · Updated: 2026-03-14T23:03:17.077951