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

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DESCRIPTION
Drug Facts

Active Ingredient (in each dose)

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

Purpose

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
  • side effects occur.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a POISON CONTROL CENTER right away.

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 Ingredients

none

How Supplied

Active Ingredient in each dose is Polyethylene Glycol 3350, 17 g (cap filled to line).......Laxative

 

238g - 68788-9849-2

Questions or comments?

1-866-403-7592

Relabeled By Preferred Pharmaceuticals, Inc

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GaviLAX label
GAVILAX 
polyethylene glycol-3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68788-9849(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
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-9849-2238 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09107703/29/2012
Labeler - Preferred Pharmaceuticals, Inc (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc791119022RELABEL(68788-9849)

Revised: 3/2012
 
Preferred Pharmaceuticals, Inc