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Polyethylene Glycol-3350 by Novel Laboratories, Inc.

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

Revised: 10/2009
 
Novel Laboratories, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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