G
polyethylene glycol-3350
Dosage Form: powder, for solution
Gavilax (Polyethylene Glycol 3350, Powder for Oral Solution)
DESCRIPTION
Drug Facts
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
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
NDC Product Code (Source)
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
Inactive Ingredients
Ingredient Name
Strength
No Inactive Ingredients Found
Product Characteristics
Color
WHITE
Score
Shape
Size
Flavor
Imprint Code
Contains
Packaging
#
NDC
Package Description
Multilevel Packaging
1
43386-312-08
14 DOSE PACK In 1 BOTTLE
None
2
43386-312-14
30 DOSE PACK In 1 BOTTLE
None
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, ANALYSIS
Establishment
Name
Address
ID/FEI
Operations
Dow Chemical Company
801038019
api manufacture, MANUFACTURE
Revised: 10/2009GAVIS Pharmaceuticals, LLC
More Gavilax resources
Gavilax Side Effects (in more detail)
Gavilax Use in Pregnancy & Breastfeeding
Gavilax Drug Interactions
Gavilax Support Group
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