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 doctor or pharmacist before use if you are

taking a prescription drug

When using this product

you may 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.

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 (clear section in cap)
adults and children 17 years of age and older:
○ fill to top of clear 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
○ 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 foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken

Inactive ingredient

none

Questions or comments?

1-800-FDA-1088

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 04/19IT

PRINCIPAL DISPLAY PANEL

NDC 10135-0683-04
Polyethylene Glycol
3350
Powder for Solution, Osmotic Laxative
Net Wt 4.1 oz (119 g)
7 Once-Daily Doses

PRINCIPAL DISPLAY PANEL
NDC 10135-0683-04
Polyethylene Glycol
3350
Powder for Solution, Osmotic Laxative
Net Wt 4.1 oz (119 g)
7 Once-Daily Doses

PRINCIPAL DISPLAY PANEL

NDC 10135-0683-08
Polyethylene Glycol
3350
Powder for Solution, Osmotic Laxative
Net Wt 8.3 oz (238 g)
14 Once-Daily Doses

PRINCIPAL DISPLAY PANEL
NDC 10135-0683-08
Polyethylene Glycol
3350
Powder for Solution, Osmotic Laxative
Net Wt 8.3 oz (238 g)
14 Once-Daily Doses

PRINCIPAL DISPLAY PANEL

NDC 10135-0683-12
Polyethylene Glycol
3350
Powder for Solution, Osmotic Laxative
Net Wt 17.9 oz (510 g)
30 Once-Daily Doses

PRINCIPAL DISPLAY PANEL
NDC 10135-0683-12
Polyethylene Glycol
3350
Powder for Solution, Osmotic Laxative
Net Wt 17.9 oz (510 g)
30 Once-Daily Doses

POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10135-683
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	17 g in 17 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10135-683-04	119 g in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2019
2	NDC:10135-683-08	238 g in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2019
3	NDC:10135-683-12	510 g in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202071	04/01/2019

Labeler - Marlex Pharmaceuticals Inc (782540215)