Polyethylene Glycol 3350 Powder For Solution

Polyethylene Glycol 3350 Powder For Solution
SPL v1
SPL
SPL Set ID ae595e97-6d29-44f8-a647-fcd54fcda5b1
Route
TOPICAL
Published
Effective Date 2025-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 3350 (17 g)

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-10-01

Description

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

Purpose

Osmotic Laxative


Medication Information

Purpose

Osmotic Laxative

Description

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

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

• 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 (17g)

• 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 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

Drug Facts

Other Information

• store at 20° - 25°C (68° - 77°F)

• tamper-evident: do not use if printed foil seal under cap is missing, open or broken

Package Labeling:

Inactive Ingredients

none

Questions Or Comments?

1-800-403-9832

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, 17 g (cap filled to line)

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

• 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 (17g)

• 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 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

Drug Facts

Other Information (Other information)

• store at 20° - 25°C (68° - 77°F)

• tamper-evident: do not use if printed foil seal under cap is missing, open or broken

Package Labeling:

Inactive Ingredients (Inactive ingredients)

none

Questions Or Comments? (Questions or comments?)

1-800-403-9832

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, 17 g (cap filled to line)

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

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