473 - Peg 3350 Powder

473 - Peg 3350 Powder
SPL v1
SPL
SPL Set ID 13851c9a-a226-481b-9db5-bc7053997df7
Route
ORAL
Published
Effective Date 2025-03-17
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 2025-03-17
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(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.

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
Questions/comments

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

Active Ingredient(s)

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

Inactive Ingredients

None

Principal Display Panel

PEG 3350 Powder 510g
PEG 3350 Powder 238g

When Using This Product

you may have loose, watery, more frequent stools

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
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.

Ask A Doctor Or Pharmacist Before Use If

you are taking a prescription drug



Structured Label Content

Use(s)
  • 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 (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
Questions/comments (Questions/Comments)

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

Active Ingredient(s) (Active ingredient(s))

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

Inactive Ingredients (Inactive ingredients)

None

Principal Display Panel

PEG 3350 Powder 510g
PEG 3350 Powder 238g

When Using This Product (When using this product)

you may have loose, watery, more frequent stools

Ask A Doctor Before Use If (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
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 Breastfeeding, (If pregnant or breastfeeding,)

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

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are taking a prescription drug



Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:43.874571 · Updated: 2026-03-14T23:08:01.024401