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 Breeckenridge Pharmaceutical, Inc., Nexgen Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 grams (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:
  • fill to the indicated "17 GRAMS" line on cup which is marked to indicate the correct dose 17 grams
  • stir and dissolve 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 not drink if there are any clumps.
  • use once a day
  • use no more than 7 days
• children 16 years of age or younger: ask a doctor

Other information

• store at 20° - 25°C (68° - 77°F)
• tamper-evident: do not use if 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

SPL UNCLASSIFIED SECTION

Manufactured by:
Nexgen Pharma, Inc.
Irvine, CA 92606

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

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

Breckenridge
Pharmaceutical, Inc.

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

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

Breckenridge
Pharmaceutical, Inc.

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51991-961
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: 51991-961-58	238 g in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090812	03/27/2019

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51991-962
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: 51991-962-57	510 g in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090812	03/27/2019

Labeler - Breeckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		160356114	MANUFACTURE(51991-961, 51991-962)