Polyethylene Glycol 3350, NF Powder for Oral Solution

Polyethylene Glycol 3350 by

Drug Labeling and Warnings

Polyethylene Glycol 3350 by is a Prescription medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

POLYETHYLENE GLYCOL 3350- polyethylene glycol 3350 powder, for solution 
Bryant Ranch Prepack

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Polyethylene Glycol 3350, NF Powder for Oral Solution

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

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

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

HOW SUPPLIED

NDC: 63629-2061-1: 238 grams Powder 17 g/dose in a BOTTLE

Polyethylene Glycol 3350 17 g, #238gm

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 63629-2061(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: 63629-2061-1	238 g in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090812	03/27/2019	04/29/2021

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(63629-2061) , RELABEL(63629-2061)

Revised: 4/2021

Document Id: 77b39442-cb0c-49ab-b8b0-4a78c55dd389

34391-3

Set id: ddc9c721-c3cb-4f97-8607-1dadf7566804

Version: 101

Effective Time: 20210429