Polyethylene Glycol 3350 Powder For Oral Solution, 17 G

Polyethylene Glycol 3350 Powder For Oral Solution, 17 G
SPL v2
SPL
SPL Set ID cccbe459-813d-4668-8cd2-76be82906a32
Route
ORAL
Published
Effective Date 2025-09-09
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 2024-03-08

Description

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

Purpose

Osmotic Laxative


Medication Information

Purpose

Osmotic Laxative

Description

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

(Bottle 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:

   • use once a day

   • fill to top of white 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

   • do not combine with starch-based thickeners used for difficult 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



  (Packet Only)



 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 difficult 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

Other Information

• store at 20° to 25°C (68° to 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

Questions Or Comments?

call 1-888-588-1418.

Principal Display Panel

Polyethylene glycol 3350 powder for oral solution bottle label

 68788-8601-2

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

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. 

Active Ingredient (in Each Dose)

(Bottle Only)            





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





(Packet Only)            





Polyethylene Glycol 3350, 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 (USE)

• relieves occasional constipation (irregularity)

• generally produces a bowel movement in 1 to 3 days

Purpose (PURPOSE)

Osmotic Laxative

Warnings (WARNINGS)

Allergy alert: Do not use if you are allergic to polyethylene glycol

Directions (DIRECTIONS)

(Bottle 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:

   • use once a day

   • fill to top of white 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

   • do not combine with starch-based thickeners used for difficult 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



  (Packet Only)



 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 difficult 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

Other Information (OTHER INFORMATION)

• store at 20° to 25°C (68° to 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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

call 1-888-588-1418.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Polyethylene glycol 3350 powder for oral solution bottle label

 68788-8601-2

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

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. 

Active Ingredient (in Each Dose) (ACTIVE INGREDIENT (IN EACH DOSE))

(Bottle Only)            





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





(Packet Only)            





Polyethylene Glycol 3350, 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)