Polyethylene Glycol 3350

Polyethylene Glycol 3350
SPL v5
SPL
SPL Set ID 173a62cb-9b20-4b50-e063-6294a90ac36b
Route
ORAL
Published
Effective Date 2024-07-01
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 Completed Since 2024-08-01 Until 2026-09-30
Description

Polyethylene Glycol 3350 USP, 17g

Purpose

Osmotic Laxative

Medication Information

Purpose

Osmotic Laxative

Description

Polyethylene Glycol 3350 USP, 17g

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Section 42229-5

Packaged by:

Novitium Pharma LLC

East Windsor, NJ 08520

Distributed by:

McKesson Corporation dba SKY Packaging

Memphis, TN 38141

Issued: 05/2024

LB4717-00

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 one packet of powder (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 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° to 25°C (68° to 77°F)
  • tamper-evident: do not use if printed foil pouch is open or broken
Inactive Ingredients

None

Questions Or Comments?

1-888-243-4363

Principal Display Panel

NDC 63739-760-03

Polyethylene Glycol 3350

Powder for Solution,

Osmotic Laxative

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

Dissolves in any Beverage

Sugar free

30 Once-Daily Doses

30 Packets NET WT 0.5 oz (17 g) Each

30 Single Doses

Compare to MiraLAX ®Active Ingredient

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, 17g

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
Section 42229-5 (42229-5)

Packaged by:

Novitium Pharma LLC

East Windsor, NJ 08520

Distributed by:

McKesson Corporation dba SKY Packaging

Memphis, TN 38141

Issued: 05/2024

LB4717-00

Purpose

Osmotic Laxative

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 one packet of powder (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 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° to 25°C (68° to 77°F)
  • tamper-evident: do not use if printed foil pouch is open or broken
Inactive Ingredients (Inactive ingredients)

None

Questions Or Comments? (Questions or comments?)

1-888-243-4363

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 63739-760-03

Polyethylene Glycol 3350

Powder for Solution,

Osmotic Laxative

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

Dissolves in any Beverage

Sugar free

30 Once-Daily Doses

30 Packets NET WT 0.5 oz (17 g) Each

30 Single Doses

Compare to MiraLAX ®Active Ingredient

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, 17g

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: 2026-02-15T12:06:07.429298 · Updated: 2026-03-14T23:08:42.212838