POLYETHYLENE GLYCOL- polyethylene glycol powder, for suspension 
BluePoint Laboratories

----------

ACTIVE INGREDIENT

Polyethylene Glycol 3350, 17 g (cap filled to 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

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

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF THE REACH OF CHILDREN

In case of overdose, get medical help or contact a POISON CONTROL CENTER right away. (1-800-222-1222)

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

None

QUESTIONS OR COMMENTS?

1-866-403-7592

Package Label - Principal Display Panel

NDC: 68001-505-55

Original Prescription Strength

Polyethylene Glycol 3350

Powder for Solution, 17g/dose

Osmotic Laxative

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

Label

POLYETHYLENE GLYCOL 
polyethylene glycol powder, for suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-505
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
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68001-505-55238 g in 1 BOTTLE; Type 0: Not a Combination Product06/18/2021
2NDC:68001-505-69510 g in 1 BOTTLE; Type 0: Not a Combination Product06/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09107706/18/2021
Labeler - BluePoint Laboratories (985523874)
Establishment
NameAddressID/FEIBusiness Operations
Novel Laboratories Inc.793518643analysis(68001-505) , manufacture(68001-505) , pack(68001-505)

Revised: 9/2021
Document Id: cc6e2865-14e2-1ac7-e053-2a95a90acbc0
Set id: c4cae70c-68da-0bbc-e053-2a95a90a395a
Version: 3
Effective Time: 20210920
 
BluePoint Laboratories