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GAVILAX by Lupin Pharmaceuticals,Inc.

Dosage form: powder, for solution
Ingredients: POLYETHYLENE GLYCOL 3350 17g in 17g
Labeler: Lupin Pharmaceuticals,Inc.
NDC Code: 43386-312

Drug Facts

Active Ingredient

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

Purpose

Osmotic Laxative

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:
  • 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
  • use once a day
  • use no 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 is missing, open or broken

Inactive Ingredient

none

Questions or comments?

1-866-403-7592

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:43386-312
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 335017 g  in 17 g
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:43386-312-07119 g in 1 BOTTLE
2NDC:43386-312-85850 g in 1 BOTTLE
3NDC:43386-312-14510 g in 1 BOTTLE
4NDC:43386-312-08238 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09107710/09/2009
Labeler - Lupin Pharmaceuticals,Inc. (089153071)
Registrant - Novel Laboratories, Inc. (793518643)
Establishment
NameAddressID/FEIOperations
Novel Laboratories, Inc.793518643ANALYSIS(43386-312), MANUFACTURE(43386-312), PACK(43386-312)

 
Lupin Pharmaceuticals,Inc.

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Medically reviewed on Sep 22, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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