POLYETHYLENE GLYCOL 3350- polyethylene glycol 3350 powder, for solution 
Padagis Israel Pharmaceuticals Ltd

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Polyethylene Glycol 3350 Drug Facts

Active ingredient (in each dose)

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 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 (white section in cap)
adults and children 17 years of age and older:
use once a day
fill to top of white section 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 is missing, open or broken

Inactive ingredients

none

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to MiraLAX® active ingredient

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

- Relieves Occasional Constipation/Irregularity

- Softens Stool

Unflavored Powder

Grit Free

NET WT 8.3 OZ (238 g)

14 Once-Daily Doses

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POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-868
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
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45802-868-01119 g in 1 BOTTLE; Type 0: Not a Combination Product11/06/2009
2NDC:45802-868-03510 g in 1 BOTTLE; Type 0: Not a Combination Product11/05/2009
3NDC:45802-868-02238 g in 1 BOTTLE; Type 0: Not a Combination Product11/04/2009
4NDC:45802-868-6614 in 1 CARTON07/16/2018
417 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09068510/13/2009
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 1/2023
Document Id: 1a88ad2b-b557-4991-aff2-a1f96159bbdc
Set id: e138b8c8-48de-48cd-8baa-2cc148cef62c
Version: 9
Effective Time: 20230115
 
Padagis Israel Pharmaceuticals Ltd