drug facts

drug facts
SPL v8
SPL
SPL Set ID 19672e23-1606-497e-a112-939af33af195
Route
oral
Published
Effective Date 2025-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
polyethylene glycol 3350 (17 g)
Inactive Ingredients
sodium hydroxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
anda active Since 2009-10-09
Purpose

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

Description

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

Medication Information

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

Purpose

Use

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
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.
  • adults and children 17 years of age and older:
  • use once a day
  • fill to top of line 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 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 printed foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Description

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

Active Ingredient

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

Inactive Ingredient

none

Questions Or Comments?

1-866-403-7592

  • Dissolves in any beverages
  • Sugar Free
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 the 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 are taking a prescription drug

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

Package Label.principal Display Panel

NDC 43386-312-08

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

NDC 43386-312-85

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

50 ONCE-DAILY DOSES

NET WT 29.9 OZ (850 g)

NDC 43386-312-07

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

7 ONCE-DAILY DOSES

NET WT 4.1 OZ (119 g)

NDC 43386-312-14

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)

Structured Label Content

Warnings (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

Purpose

Use

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
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.
  • adults and children 17 years of age and older:
  • use once a day
  • fill to top of line 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 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 printed foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Active Ingredient

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

Inactive Ingredient

none

Questions Or Comments? (Questions or comments?)

1-866-403-7592

  • Dissolves in any beverages
  • Sugar Free
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, ask a health professional before use.

Keep Out of the Reach of Children (Keep out of the 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 are taking a prescription drug

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

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 43386-312-08

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

NDC 43386-312-85

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

50 ONCE-DAILY DOSES

NET WT 29.9 OZ (850 g)

NDC 43386-312-07

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

7 ONCE-DAILY DOSES

NET WT 4.1 OZ (119 g)

NDC 43386-312-14

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:31.665549 · Updated: 2026-03-14T23:11:05.615438