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 Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each dose)

Polyethylene Glycol 3350, USP, 17 g

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.

Directions

• do not take more than directed unless advised by your doctor
• adults and children 17 years of age and older:
  • stir and dissolve the contents of one pouch (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
  • ensure that the powder is fully dissolved before drinking
  • do no drink if there are any clumps
  • 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° to 25°C (68° to 77°F)
• tamper-evident: do not use if pouch is damaged or torn
• keep carton for future reference
• for institutional use only

Inactive ingredients

none

Questions or comments?

1-877-4-INFO-RX (1-877-446-3679)

Manufactured for:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

MII306-30:R6

Distributed By:

Cardinal Health

Dublin, OH 43017

L4591186-10618

L4591186-20618

Principal Display Panel

Polyethylene Glycol 3350, USP

Powder For Solution, Osmotic Laxative

5 Single-Dose Pouches

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL (3350) 
polyethylene glycol (3350) powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-5383(NDC:51079-306)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 3500 (UNII: FVS1AZD90Y) (POLYETHYLENE GLYCOL 3500 - UNII:FVS1AZD90Y)	POLYETHYLENE GLYCOL 3500	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: 55154-5383-5	5 in 1 BAG	11/20/2009
1		17 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078915	11/20/2009

Labeler - Cardinal Health (603638201)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		080089848	REPACK(55154-5383)