POLYETHYLENE GLYCOL 3350- polyethylene glycol 3350 powder, for solution 
BluePoint Laboratories

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Polyethylene Glycol 3350 Powder for Oral Solution, 17 g

ACTIVE INGREDIENT (IN EACH DOSE)

Polyethylene Glycol 3350, 17 g (cap filled to 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
• the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
• adults and children 17 years of age and older:

• use once a day
• fill to top of white section in cap 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 difficult 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° to 25°C (68° to 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 1-888-588-1418.

PRINCIPAL DISPLAY PANEL

Polyethylene glycol 3350 powder for oral solution 238g bottle label

bottlelabelfront

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Polyethylene glycol 3350 powder for oral solution 510g bottle label

510g front label510g back label

Polythylene Glycol Powder 238g Label Page 1 Rev 012024

Polythylene Glycol Powder 238g Label Page 1 Rev 012024

Polythylene Glycol Powder 238g Label Page 2 Rev 012024

Polythylene Glycol Powder 238g Label Page 2 Rev 012024

Polythylene Glycol Powder 510g Label Page 1 Rev 012024

Polythylene Glycol Powder 510g Label Page 1 Rev 012024

Polythylene Glycol Powder 510g Label Page 2 Rev 012024

Polythylene Glycol Powder 510g Label Page 2 Rev 012024

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-607
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:68001-607-55238 g in 1 BOTTLE; Type 0: Not a Combination Product10/01/2023
2NDC:68001-607-69510 g in 1 BOTTLE; Type 0: Not a Combination Product10/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21499010/01/2023
Labeler - BluePoint Laboratories (985523874)
Establishment
NameAddressID/FEIBusiness Operations
Annora Pharma Private Limited650980746manufacture(68001-607)

Revised: 1/2024
Document Id: 12fe5bcd-8ad0-e159-e063-6294a90a444e
Set id: 02e36812-53c2-003b-e063-6394a90aed12
Version: 2
Effective Time: 20240131
 
BluePoint Laboratories