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

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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

Relabeled by Preferred Pharmaceuticals, Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68788-7508-02

Original Prescription Strength

GaviLax

Polyethylene Glycol 3350

Powder for Solution, Osmotic Laxative

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

GaviLAX
GAVILAX 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7508(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:68788-7508-2238 g in 1 BOTTLE; Type 0: Not a Combination Product10/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09107710/09/2009
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-7508)

Revised: 5/2021
Document Id: 09e00626-32af-48b3-8e91-1100b7a286ac
Set id: 21654def-5ae0-422d-961b-1fe2456af00a
Version: 3
Effective Time: 20210524
 
Preferred Pharmaceuticals, Inc.