Polyethylene Glycol 3350 Powder, For Solution

Polyethylene Glycol 3350 Powder, For Solution
SPL v3
SPL
SPL Set ID 49c3aa94-3b32-4929-b9c6-52e3f58e4a57
Route
ORAL
Published
Effective Date 2014-04-22
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 2017-07-03
Description

Drug Facts

Purpose

Osmotic Laxative

Medication Information

Purpose

Osmotic Laxative

Description

Drug Facts

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

Drug Facts

Warnings

Allergy alert:

Do not use if you are allergic to polyethylene glycol

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

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 (clear section in cap)
  • adults and children 17 years of age and older:

    ○ fill to top of clear section in cap which is marked to indicate the correct dose (17 g)

    ○ stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink

    ○ use once a day

    ○ use no more than 7 days

  • children 16 years of age or under: ask a doctor
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 Ingredient

None

Questions Or Comments?

1-800-FDA-1088

Distributed by:

Nuvo Pharmaceutical, Inc.

Rahway, NJ 07065

Manufactured by:

Sunrise Pharmaceutical, Inc.

Rahway, NJ 07065

When Using This Product

you may 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
Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use

Principal Display Panel 119 G Per Bottle

NDC 425756-180-19

Polyethylene Glycol

3350

Powder for Solution, Osmotic Laxative

  • Relieves Occasional

    Constipation/Irregularity

  • Softens Stool
  • Dissolves in Any Beverage

    Unflavored Powder Grit Free

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

    PRINCIPAL DISPLAY PANEL -238 g per Bottle

    NDC 425756-180-28

    Polyethylene Glycol

    3350

    Powder for Solution, Osmotic Laxative

  • Relieves Occasional

    Constipation/Irregularity

  • Softens Stool
  • Dissolves in Any Beverage

    Unflavored Powder Grit Free

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

    PRINCIPAL DISPLAY PANEL -510 g per Bottle

    NDC 425756-180-50

    Polyethylene Glycol

    3350

    Powder for Solution, Osmotic Laxative

  • Relieves Occasional

    Constipation/Irregularity

  • Softens Stool
  • Dissolves in Any Beverage

  • Unflavored Powder Grit Free

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

Ask Doctor Or Pharmacist Before Use If You Are

taking a prescription drug

Active Ingredient (in Each Dose)                     

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

Structured Label Content

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

Drug Facts

Purpose

Osmotic Laxative

Warnings

Allergy alert:

Do not use if you are allergic to polyethylene glycol

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

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 (clear section in cap)
  • adults and children 17 years of age and older:

    ○ fill to top of clear section in cap which is marked to indicate the correct dose (17 g)

    ○ stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink

    ○ use once a day

    ○ use no more than 7 days

  • children 16 years of age or under: ask a doctor
Other Information (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 Ingredient (INACTIVE INGREDIENT)

None

Questions Or Comments? (Questions or comments?)

1-800-FDA-1088

Distributed by:

Nuvo Pharmaceutical, Inc.

Rahway, NJ 07065

Manufactured by:

Sunrise Pharmaceutical, Inc.

Rahway, NJ 07065

When Using This Product (When Using this product)

you may 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
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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Principal Display Panel 119 G Per Bottle (PRINCIPAL DISPLAY PANEL-119 g per Bottle)

NDC 425756-180-19

Polyethylene Glycol

3350

Powder for Solution, Osmotic Laxative

  • Relieves Occasional

    Constipation/Irregularity

  • Softens Stool
  • Dissolves in Any Beverage

    Unflavored Powder Grit Free

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

    PRINCIPAL DISPLAY PANEL -238 g per Bottle

    NDC 425756-180-28

    Polyethylene Glycol

    3350

    Powder for Solution, Osmotic Laxative

  • Relieves Occasional

    Constipation/Irregularity

  • Softens Stool
  • Dissolves in Any Beverage

    Unflavored Powder Grit Free

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

    PRINCIPAL DISPLAY PANEL -510 g per Bottle

    NDC 425756-180-50

    Polyethylene Glycol

    3350

    Powder for Solution, Osmotic Laxative

  • Relieves Occasional

    Constipation/Irregularity

  • Softens Stool
  • Dissolves in Any Beverage

  • Unflavored Powder Grit Free

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

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

taking a prescription drug

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:22.909837 · Updated: 2026-03-14T22:54:47.454101