Polyethylene Glycol 3350 Powder For Oral Solution, 17 G

Polyethylene Glycol 3350 Powder For Oral Solution, 17 G
SPL v2
SPL
SPL Set ID 02e36812-53c2-003b-e063-6394a90aed12
Route
ORAL
Published
Effective Date 2023-02-22
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 2023-10-01

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 (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



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 238g bottle label

Polyethylene glycol 3350 powder for oral solution 510g bottle label

Polythylene Glycol Powder 238g Label Page 1 Rev 012024

Polythylene Glycol Powder 238g Label Page 2 Rev 012024

Polythylene Glycol Powder 510g Label Page 1 Rev 012024

Polythylene Glycol Powder 510g Label Page 2 Rev 012024

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)

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 (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)





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



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 238g bottle label

Polyethylene glycol 3350 powder for oral solution 510g bottle label

Polythylene Glycol Powder 238g Label Page 1 Rev 012024

Polythylene Glycol Powder 238g Label Page 2 Rev 012024

Polythylene Glycol Powder 510g Label Page 1 Rev 012024

Polythylene Glycol Powder 510g Label Page 2 Rev 012024

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))

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

All Sections (JSON)