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Polyethylene Glycol-3350 by Novel Laboratories, Inc.

Medically reviewed on Oct 8, 2018

Dosage form: powder, for solution
Ingredients: POLYETHYLENE GLYCOL 3350 17g in 17g
Labeler: Novel Laboratories, Inc.
NDC Code: 40032-312

Polyethylene Glycol 3350, Powder for Oral Solution

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

POLYETHYLENE GLYCOL-3350 
polyethylene glycol-3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40032-312
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 335017 g  in 17 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:40032-312-07119 g in 1 BOTTLE
2NDC:40032-312-08238 g in 1 BOTTLE
3NDC:40032-312-14510 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09107710/06/2009
Labeler - Novel Laboratories, Inc. (793518643)
ContactAddressTelephone NumberEmail Address
Anu Radha Subramanian
Address:400 Campus Drive
City, State, Zip:Somerset, NJ, 08873
Country:USA
++1908-603-6000;ext=6002ars@novellabs.net
Registrant - Novel Laboratories, Inc. (793518643)
Establishment
NameAddressID/FEIOperations
Novel Laboratories, Inc.793518643MANUFACTURE, ANALYSIS, repack
Establishment
NameAddressID/FEIOperations
Dow Chemical Company801038019api manufacture

 
Novel Laboratories, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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