POLYETHYLENE GLYCOL 3350- polyethylene glycol 3350 powder, for solution 
Lannett Company, Inc.

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Drug Facts

Active ingredient

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

Purpose

Laxative

Uses

  • 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.

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 17 grams line in cap for the correct dose
    • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • use once daily
    • 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

Questions or comments?

1-800-477-7877

Distributed by

Kremers Urban, LLC

Princeton, NJ 08540 USA

Rev. 1E

Principal Display Panel

Original Prescription Strength

  • Relieves Occasional Constipation
  • Softens Stool
  • 4.1 oz Label

    4.1 oz Label. Drug Facts on ECL.

  • 8.9 oz Label

    8.9 oz Label. Drug Facts on ECL.

  • 18.5 oz Label

    18.5 oz Label. Drug Facts on ECL.

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62175-195
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
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62175-195-07119 g in 1 BOTTLE; Type 0: Not a Combination Product10/06/200902/29/2012
2NDC:62175-195-15255 g in 1 BOTTLE; Type 0: Not a Combination Product10/06/200902/28/2013
3NDC:62175-195-31527 g in 1 BOTTLE; Type 0: Not a Combination Product10/06/200902/28/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09060010/06/200902/28/2013
Labeler - Lannett Company, Inc. (006422406)

Revised: 3/2010
Document Id: 65489485-97fb-43e4-b582-6d9feeba2e0a
Set id: 17d62f30-c6c6-49fe-bbf6-fed0f36e2b16
Version: 7
Effective Time: 20100305
 
Lannett Company, Inc.