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 BluePoint Laboratories, Annora Pharma Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Polyethylene glycol 3350 powder for oral solution 510g bottle label

Polythylene Glycol Powder 238g Label Page 1 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 2 Rev 012024

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-607
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: 68001-607-55	238 g in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2023
2	NDC: 68001-607-69	510 g in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214990	10/01/2023

Labeler - BluePoint Laboratories (985523874)

Establishment
Name	Address	ID/FEI	Business Operations
Annora Pharma Private Limited		650980746	manufacture(68001-607)