Pv Peg

Pv Peg
SPL v5
SPL
SPL Set ID 60cc2d39-745c-87a4-e053-2a91aa0a8a42
Route
ORAL
Published
Effective Date 2016-09-13
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 2015-06-01 Until 2026-03-30

Description

Polyethylene Glycol 3350, 17 grams (cap filled to the indicated “17 GRAMS” line)

Purpose

Osmotic Laxative


Medication Information

Purpose

Osmotic Laxative

Description

Polyethylene Glycol 3350, 17 grams (cap filled to the indicated “17 GRAMS” line)

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

Section 50565-1

Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center right away.

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 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

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.

Directions
  • do not take more than directed unless advised by your doctor
  • the bottle top is a measuring cup marked to contain 17 grams of powder when filled to the indicated “17 GRAMS” line
  • adults and children 17 years of age and older:
  • use once a day
    • fill to indicated “17 GRAMS” line in cap which is marked to indicate the correct dose 17 grams
  • 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

Package 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

Questions Or Comments?

1-877-288-1495

Active Ingredient (in Each Dose)

Polyethylene Glycol 3350, 17 grams (cap filled to the indicated “17 GRAMS” line)


Structured Label Content

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

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center right away.

Purpose

Osmotic Laxative

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 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

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.

Directions
  • do not take more than directed unless advised by your doctor
  • the bottle top is a measuring cup marked to contain 17 grams of powder when filled to the indicated “17 GRAMS” line
  • adults and children 17 years of age and older:
  • use once a day
    • fill to indicated “17 GRAMS” line in cap which is marked to indicate the correct dose 17 grams
  • 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

Package Label (Package label)

Other Information (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

Questions Or Comments? (Questions or comments?)

1-877-288-1495

Active Ingredient (in Each Dose) (Active ingredient (in each dose))

Polyethylene Glycol 3350, 17 grams (cap filled to the indicated “17 GRAMS” line)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)