Gc Peg 489

Gc Peg 489
SPL v102
SPL
SPL Set ID 66276671-0ccd-4c32-a697-31e679fce0e3
Route
ORAL
Published
Effective Date 2024-02-02
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 2014-05-01

Description

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

Purpose

Osmotic Laxative

How Supplied

NDC: 72162-2180-2: 238 g in a BOTTLE NDC: 72162-2180-4: 510 g in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504


Medication Information

Purpose

Osmotic Laxative

How Supplied

NDC: 72162-2180-2: 238 g in a BOTTLE

NDC: 72162-2180-4: 510 g in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

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

Uses
  • 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.

Section 51945-4

Polyethylene Glycol 3350 Powder

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

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?

1-800-540-3765

Active Ingredient (in Each Dose)

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


Structured Label Content

Uses
  • 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.

Section 51945-4 (51945-4)

Polyethylene Glycol 3350 Powder

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

How Supplied (HOW SUPPLIED)

NDC: 72162-2180-2: 238 g in a BOTTLE

NDC: 72162-2180-4: 510 g in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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?)

1-800-540-3765

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)