GAVILAX- polyethylene glycol 3350 powder, for solution 
Lupin Pharmaceuticals,Inc.

----------

Drug Facts

Active Ingredient

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

Purpose

Osmotic Laxative

Use

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

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

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

Other Information

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)

238 grams

238-part2 gram

NDC 43386-312-14

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Solution, Osmotic Laxative

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)

510 grams

GAVILAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43386-312
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 335017 g  in 17 g
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43386-312-07119 g in 1 BOTTLE; Type 0: Not a Combination Product10/09/2009
2NDC:43386-312-85850 g in 1 BOTTLE; Type 0: Not a Combination Product10/09/2009
3NDC:43386-312-14510 g in 1 BOTTLE; Type 0: Not a Combination Product10/09/2009
4NDC:43386-312-08238 g in 1 BOTTLE; Type 0: Not a Combination Product10/09/2009
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/FEIBusiness Operations
Novel Laboratories, Inc.793518643analysis(43386-312) , manufacture(43386-312) , pack(43386-312)

Revised: 12/2020
Document Id: b57f10a3-44c8-a1f9-e053-2a95a90a46ad
Set id: 19672e23-1606-497e-a112-939af33af195
Version: 4
Effective Time: 20201202
 
Lupin Pharmaceuticals,Inc.