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 g (cup filled to the indicated "17 GRAMS" line)

Purpose

Osmotic Laxative

Use

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

Other information

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: 63629-8541-1: 238 g in a BOTTLE

Polyethylene Glycol 3350 Powder

Label
POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-8541(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:63629-8541-1238 g in 1 BOTTLE; Type 0: Not a Combination Product09/02/202209/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09081203/27/201909/30/2024
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-8541) , RELABEL(63629-8541)

Revised: 2/2024
Document Id: 71f0acfb-00b2-4802-924b-ed0525a66e64
Set id: 95988697-dd24-434a-89b0-02c2c43f8ab6
Version: 104
Effective Time: 20240226
 
Bryant Ranch Prepack