POLYTHYLENE GLYCOL powder, for solution

POLYTHYLENE GLYCOL by

Drug Labeling and Warnings

POLYTHYLENE GLYCOL by is a Otc medication manufactured, distributed, or labeled by DIRECT RX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Polyethylene Glycol 3350, 17 grams (cup filled to the indicated "17 GRAMS" line)

PURPOSE

Osmotic Laxative

USE IN SPECIFIC POPULATIONS

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.

MEDICATION GUIDE

do not take more than directed unless advised by your doctor
This product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line.
adults and children 17 years of age and older:

fill to indicated "17 GRAMS" line on cup which is marked to indicate the correct dose 17 grams
stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
use once a day
use no more than 7 days

children 16 years of age or younger: ask a doctor

OTHER SAFETY INFORMATION

store at 20° - 25°C (68° - 77°F)
tamper-evident: do not use if seal under cap printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

DOSAGE & ADMINISTRATION

ACTIVE INGREDIENT

INACTIVE INGREDIENT

none

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

relieves occasional constipation (irregularity)
generally produces a bowel movement in 1 to 3 days

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POLYTHYLENE GLYCOL 
polythylene glycol powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-879(NDC:51991-961)
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: 61919-879-51	510 g in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2019	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090812	07/30/2019	12/31/2023

Labeler - DIRECT RX (079254320)

Registrant - DIRECT RX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECT RX		079254320	relabel(61919-879)