POLYETHYLENE GLYCOL 3350- polyethylene glycol 3350 powder, for solution 
Breeckenridge Pharmaceutical, Inc.

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Polyethylene Glycol 3350, NF Powder for Oral Solution

Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 g (cup filled to the indicated "17 GRAMS" 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.

Directions

  • do not take more than directed unless advised by your doctor
  • this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line
  • adults and children 17 years of age and older:
    • use once a day
    • fill to the indicated "17 GRAMS" line on cup 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 foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Inactive ingredients

none

Questions or Comments?

call: 1-800-367-3395

Manufactured by:
LGM Pharma Solutions, LLC
Irvine, CA 92614

Distributed by:
Breckenridge Pharmaceutical, Inc.
Berlin, CT 06037

PRINCIPAL DISPLAY PANEL - 238 g Bottle Label

NDC 51991-961-58

Polyethylene Glycol
3350, NF

Powder for Solution,
Osmotic Laxative

  • Relieves Occasional
    Constipation / Irregularity
  • Softens Stool
  • Unflavored Powder
  • Sugar Free

NET WT. 8.3 OZ (238 g)
14 ONCE - DAILY DOSES

breckenridge
A Towa
Company

Principal Display Panel - 238 g Bottle Label

PRINCIPAL DISPLAY PANEL - 510 g Bottle Label

NDC 51991-962-57

Polyethylene Glycol
3350, NF

Powder for Solution,
Osmotic Laxative

  • Relieves Occasional
    Constipation/ Irregularity
  • Softens Stool
  • Unflavored Powder
  • Sugar Free

NET WT 17.9 OZ (510 g)
30 ONCE - DAILY DOSES

breckenridge
A Towa
Company

Principal Display Panel - 510 g Bottle Label
POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51991-961
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:51991-961-58238 g in 1 BOTTLE; Type 0: Not a Combination Product03/27/201909/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09081203/27/201909/30/2024
POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51991-962
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:51991-962-57510 g in 1 BOTTLE; Type 0: Not a Combination Product03/27/201907/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09081203/27/201909/30/2024
Labeler - Breeckenridge Pharmaceutical, Inc. (150554335)
Establishment
NameAddressID/FEIBusiness Operations
LGM Pharma Solutions, LLC117549200MANUFACTURE(51991-961, 51991-962)

Revised: 10/2022
 
Breeckenridge Pharmaceutical, Inc.