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 Novel Laboratories, Inc., Anu Radha Subramanian, Dow Chemical Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT

Active Ingredient (in each dose)..........................................Purpose

Polyethylene Glycol 3350, 17 g (cap filled to line).....................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

OTC - DO NOT USE

Do not use if you have kidney disease, except under the advice and supervision of a doctor

OTC - ASK 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

OTC - ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking a prescription drug

OTC - WHEN USING

When using this product you may have loose, watery, more frequent stools

OTC - STOP USE

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

• side effects occur. You may report side effects to FDA at 1-800-FDA-1088

Drug Facts (continued)

OTC - PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

OTC - 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.

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.

• adults and children 17 years of age and older:

  • fill to top of line 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

  • use once a day

  • use no 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 INGREDIENT

Inactive Ingredients                             none

OTC - QUESTIONS

Questions or comments?

1-800-FDA-1088 (1-800-332-1088) or www.fda.gov

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40032-312
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: 40032-312-07	119 g in 1 BOTTLE
2	NDC: 40032-312-08	238 g in 1 BOTTLE
3	NDC: 40032-312-14	510 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091077	10/06/2009

Labeler - Novel Laboratories, Inc. (793518643)
Contact	Address	Telephone Number	Email Address
Anu Radha Subramanian	Address: 400 Campus Drive City, State, Zip: Somerset, NJ, 08873 Country: USA	++1908-603-6000;ext=6002	ars@novellabs.net

Registrant - Novel Laboratories, Inc. (793518643)

Establishment
Name	Address	ID/FEI	Business Operations
Novel Laboratories, Inc.		793518643	MANUFACTURE, ANALYSIS, repack

Establishment
Name	Address	ID/FEI	Business Operations
Dow Chemical Company		801038019	api manufacture