DailyMed - POLYETHYLENE GYCOL 3350 powder, for solution

NDC Code(s): 69168-473-55, 69168-473-56, 69168-473-61, 69168-473-62
Packager: Allegiant Health

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 17, 2025

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

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

Osmotic Laxative
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Use(s)
relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 1 to 3 days
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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 ...
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.

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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 ...

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
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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
- 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
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Inactive ingredients
None

None
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Questions/Comments
Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST

Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST
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Principal Display Panel
PEG 3350 Powder 510g - PEG 3350 Powder 238g

PEG 3350 Powder 510g

PEG 3350 Powder 238g

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INGREDIENTS AND APPEARANCE

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	RxCUI	RxNorm NAME	RxTTY
1	876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	PSN
2	876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD
3	876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY

Label: POLYETHYLENE GYCOL 3350 powder, for solution

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Drug Label Info

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Drug Label Information

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if

When using this product

Stop use and ask a doctor if

If pregnant or breastfeeding,

Keep out of reach of children

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	69168-473-55
2	69168-473-56
3	69168-473-61
4	69168-473-62

Label: POLYETHYLENE GYCOL 3350 powder, for solution

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if

When using this product

Stop use and ask a doctor if

If pregnant or breastfeeding,

Keep out of reach of children

Find additional resources

Safety

Related Resources

More Info on this Drug

POLYETHYLENE GYCOL 3350 powder, for solution

Number of versions: 1

POLYETHYLENE GYCOL 3350 powder, for solution

POLYETHYLENE GYCOL 3350 powder, for solution

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POLYETHYLENE GYCOL 3350 powder, for solution

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.