Peg 3350

Peg 3350
SPL v2
SPL
SPL Set ID d048111f-8144-4d51-a0c2-a967b2bce455
Route
ORAL
Published
Effective Date 2025-02-13
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 2025-02-10

Description

Drug Facts

Purpose

Osmotic Laxative


Medication Information

Purpose

Osmotic Laxative

Description

Drug Facts

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Active

Polyethylene Glycol 3350, 17 g (cap filled to the top)

Section 42229-5

Drug Facts

Warnings

Allergy alert:Do not use if you are allergic to polyethylene glycol

Directions
  • d o 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 the 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

Questions Or

1-888-788-6472

Manufactured for :

Pharmaceutica North America, Inc,, Glendale, CA 912050.

Product Label

Other Information
  • store at 20° – 25°C (68° – 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

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.(1-800-222-1222)

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

taking a prescription drug


Structured Label Content

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Active

Polyethylene Glycol 3350, 17 g (cap filled to the top)

Section 42229-5 (42229-5)

Drug Facts

Purpose

Osmotic Laxative

Warnings

Allergy alert:Do not use if you are allergic to polyethylene glycol

Directions
  • d o 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 the 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

Questions Or (Questions or)

1-888-788-6472

Manufactured for :

Pharmaceutica North America, Inc,, Glendale, CA 912050.

Product Label (Product label)

Other Information
  • store at 20° – 25°C (68° – 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

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.(1-800-222-1222)

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 (Ask a doctor or pharmacist before use if you)

taking a prescription drug


Advanced Ingredient Data


Raw Label Data

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