POLYETHYLENE GLYCOL 3350 powder, for solution

Polyethylene Glycol 3350 by

Drug Labeling and Warnings

Polyethylene Glycol 3350 by is a Otc medication manufactured, distributed, or labeled by Marlex Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

MARLEX PHARMACEUTICALS, INC

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Polyethylene Glycol 3350 powder, for solution

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 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: 10135-0683-08
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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202071	04/01/2019

Labeler - Marlex Pharmaceuticals Inc (782540215)