Polyethylene Glycol 3350
Polyethylene Glycol 3350 Powder for Oral Solution, 17 g
cccbe459-813d-4668-8cd2-76be82906a32
HUMAN OTC DRUG LABEL
Sep 9, 2025
Preferred Pharmaceuticals Inc.
DUNS: 791119022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Polyethylene Glycol 3350
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (1)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Polyethylene glycol 3350 powder for oral solution bottle label
68788-8601-2
INDICATIONS & USAGE SECTION
USE
• relieves occasional constipation (irregularity)
• generally produces a bowel movement in 1 to 3 days
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN
In case of overdose, get medical help or contact a Poison Control Center right away.
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT (IN EACH DOSE)
(Bottle Only)
Polyethylene Glycol 3350, 17 g (cap filled to line)
(Packet Only)
Polyethylene Glycol 3350, 17 g
OTC - PURPOSE SECTION
PURPOSE
Osmotic Laxative
WARNINGS SECTION
WARNINGS
Allergy alert: Do not use if you are allergic to polyethylene glycol
OTC - DO NOT USE SECTION
DO NOT USE
if you have kidney disease, except under the advice and supervision of a doctor
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking a prescription drug
OTC - WHEN USING SECTION
WHEN USING THIS PRODUCT
you may have loose, watery, more frequent stools
OTC - STOP USE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS
(Bottle Only)
•** 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
(Packet Only)
•** do not take more than directed unless advised by your doctor**
• adults and children 17 years of age and older:
• use once a day
• stir and dissolve one packet of powder (17 g) 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
SPL UNCLASSIFIED SECTION
QUESTIONS OR COMMENTS?
call1-888-588-1418.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS
none