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Gavilax

Package insert / prescribing information
Generic name: polyethylene glycol-3350
Dosage form: powder, for solution
Drug class: Laxatives

Medically reviewed by Drugs.com. Last updated on Dec 1, 2021.

Active Ingredient

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

Purpose

Use

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

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.

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)

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

Inactive Ingredient

none

Questions or comments?

1-866-403-7592

  • Dissolves in any beverages
  • Sugar Free

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43386-312-08

Original Prescription Strength

Gavilax

Polyethylene Glycol 3350

Powder for 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 Solution, Osmotic Laxative

50 ONCE-DAILY DOSES

NET WT 29.9 OZ (850 g)

Gavilax
polyethylene glycol 3350 powder, for solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43386-312
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 3350 17 g in 17 g
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:43386-312-07 119 g in 1 BOTTLE
2 NDC:43386-312-85 850 g in 1 BOTTLE
3 NDC:43386-312-14 510 g in 1 BOTTLE
4 NDC:43386-312-08 238 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091077 10/09/2009
Labeler - Lupin Pharmaceuticals,Inc. (089153071)
Registrant - Novel Laboratories, Inc. (793518643)
Establishment
Name Address ID/FEI Operations
Novel Laboratories, Inc. 793518643 analysis(43386-312), manufacture(43386-312), pack(43386-312)
Lupin Pharmaceuticals,Inc.

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