GAVILAX powder, for solution

GAVILAX by

Drug Labeling and Warnings

GAVILAX by is a Prescription medication manufactured, distributed, or labeled by DirectRX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

purpose

• Osmotic Laxative

  Use

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days

WARNINGS SECTION

• 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

  Close

OTC - ASK DOCTOR SECTION

• • 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

OTC - STOP USE SECTION

• • 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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a POISON CONTROL CENTER right away. (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

• • 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GAVILAX 
gavilax powder, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61919-542(NDC:43386-312)
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 (white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-542-51	510 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091077	01/01/2015

Labeler - DirectRX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DirectRX		079254320	repack(61919-542)