Gavilax

Generic Name: polyethylene glycol-3350
Dosage Form: powder, for solution

Gavilax (Polyethylene Glycol 3350, Powder for Oral Solution)

Gavilax Description

Drug Facts

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

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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

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

  • side effects occur.

Drug Facts (continued)

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.

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 Ingredients           none

Questions or comments?

1-866-403-7592

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gavilax 
polyethylene glycol-3350 powder, for solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43386-312
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 3350 17 g
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:43386-312-08 14 POWDER, FOR SOLUTION (DOSE PACK) in 1 BOTTLE
2 NDC:43386-312-14 30 POWDER, FOR SOLUTION (DOSE PACK) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091077 10/09/2009
Labeler - GAVIS Pharmaceuticals, LLC (829838551)
Contact Address Telephone Number Email Address
Anu Radha Subramanian
Address: 400 Campus Drive
City, State, Zip: Somerset, NJ, 08873
Country: USA
++1908-603-6080 ars@gavispharma.com
Registrant - Novel Laboratories, Inc. (793518643)
Establishment
Name Address ID/FEI Operations
Novel Laboratories, Inc. 793518643 manufacture, repack, MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Dow Chemical Company 801038019 api manufacture, MANUFACTURE
Revised: 10/2009
 
GAVIS Pharmaceuticals, LLC



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