POLYETHYLENE GLYCOL 3350 POWDER FOR SOLUTION- polyethylene glycol, unspecified powder, for solution

Polyethylene Glycol 3350 Powder for Solution by

Drug Labeling and Warnings

Polyethylene Glycol 3350 Powder for Solution by is a Otc medication manufactured, distributed, or labeled by VALLEY MEDICAL PRODUCTS, LLC, Strides Pharma Science Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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 (17g)
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 difficulty 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° - 25°C (68° - 77°F)
tamper-evident: do not use if printed foil seal under cap is missing, open or broken

Inactive ingredients

none

Questions or comments?

1-800-403-9832

Package Labeling:

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 POWDER FOR SOLUTION 
polyethylene glycol, unspecified powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76470-069
Route of Administration	TOPICAL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76470-069-69	238 g in 1 JAR; Type 0: Not a Combination Product	10/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203928	10/01/2025

Labeler - VALLEY MEDICAL PRODUCTS, LLC (969389407)

Registrant - Strides Pharma Science Limited (918513263)

Establishment
Name	Address	ID/FEI	Business Operations
Strides Pharma Science Limited		918513263	manufacture(76470-069)