Polyethelene Glycol 3350, Powder for Solution

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Polyethylene Glycol 3350, Powder for Solution

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose) (Can only)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - ASK DOCTOR SECTION

Osmotic Laxative

Active ingredient (in each dose) (Packet Only)

OTC - PURPOSE SECTION

Polyethylene Glycol 3350, 17 g

Purpose

SPL UNCLASSIFIED SECTION

Osmotic Laxative

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Allergy alert:

SPL UNCLASSIFIED SECTION

Do not use if you are allergic to polyethylene glycol

OTC - DO NOT USE SECTION

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

SPL UNCLASSIFIED SECTION

• nausea, vomiting or abdominal pain
• a sudden change in bowel habits that lasts over 2 weeks
• irritable bowel syndrome

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug

OTC - WHEN USING SECTION

When using this product you may have loose, watery, more frequent stools

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions (Can Only)

DOSAGE & ADMINISTRATION SECTION

• 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:
  • ouse once a day
  • ofill to top of white section in cap which is marked to indicate the correct dose (17 g)
  • ostir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
  • odo not combine with starch-based thickeners used for difficulty swallowing
  • oensure that the powder is fully dissolved before drinking
  • odo not drink if there are any clumps
  • odo not use more than 7 days
• children 16 years of age or under: ask a doctor

Directions (Packet Only)

SPL UNCLASSIFIED SECTION

• do not take more than directed unless advised by your doctor
• adults and children 17 years of age and older:
  • ouse once a day
  • ostir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
  • odo not combine with starch-based thickeners used for difficulty swallowing
  • oensure that the powder is fully dissolved before drinking
  • odo not drink if there are any clumps
  • odo not use more than 7 days
• children 16 years of age or under: ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

• 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 INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

Call weekdays 9 AM to 5 PM at 1 (888) 721-7115.

Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.

Distributed by

Glenmark Therapeutics Inc., USA

Elmwood Park, NJ 07407

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72657-196-16 Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

• Relieves Occasional Constipation (Irregularity)
• Softens Stool
• TAMPER-EVIDENT: do not use if printed foil seal under cap is missing, open or broken
• Unflavored
• Sugar Free
• Dissolves in Any Beverage

45 ONCE-DAILY DOSES

NET WT 26.9 OZ (765 g) EACH

45s Label front

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

Product Linked Resources#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

• Polyethylene Glycol 3350

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.