POLYETHYLENE GYCOL 3350 powder, for solution

Polyethylene Gycol 3350 by

Drug Labeling and Warnings

Polyethylene Gycol 3350 by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

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

Purpose

Osmotic Laxative

Use(s)

• 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.

Do not use

if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if

• 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

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 breastfeeding,

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 (1-800-222-1222) right away.

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

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/Comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST

Principal Display Panel

PEG 3350 Powder 510g

PEG 3350 Powder 238g

INGREDIENTS AND APPEARANCE

POLYETHYLENE GYCOL 3350 
polyethylene gycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-473
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	17 g  in 1 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-473-55	510 g in 1 BOTTLE; Type 0: Not a Combination Product	03/17/2025
2	NDC: 69168-473-56	238 g in 1 BOTTLE; Type 0: Not a Combination Product	03/17/2025
3	NDC: 69168-473-61	238 g in 1 BOTTLE; Type 0: Not a Combination Product	03/17/2025
4	NDC: 69168-473-62	510 g in 1 BOTTLE; Type 0: Not a Combination Product	03/17/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214990	03/17/2025

Labeler - Allegiant Health (079501930)