polyethylene glycol 3350 powder, for solution

polyethylene glycol 3350 powder, for solution
SPL v2
SPL
SPL Set ID ce5197a1-2677-4ffb-aef2-9221b28ebd23
Route
oral
Published
Effective Date 2017-05-16
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 2017-06-13
Purpose

Osmotic Laxative

Description

Drug Facts

Medication Information

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

Purpose

Osmotic Laxative

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
Description

Drug Facts

Principal Display Panel

NDC 11534-180-19

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.

    NDC 11534-180-28

    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.

    NDC 11534-180-50

    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.

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

Drug Facts

Inactive Ingredient

none

Questions Or Comments?

1-800-FDA-1088

Manufactured & Distributed 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
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.

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

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

Purpose

Osmotic Laxative

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
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 11534-180-19

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.

    NDC 11534-180-28

    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.

    NDC 11534-180-50

    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.

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

Drug Facts

Inactive Ingredient (Inactive ingredient)

none

Questions Or Comments? (Questions or comments?)

1-800-FDA-1088

Manufactured & Distributed 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
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.

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: 2026-02-15T11:57:01.880715 · Updated: 2026-03-14T22:55:53.187482