GAVILAX- gavilax powder, for solution 
DirectRX

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GAVILAX

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

image description

GAVILAX 
gavilax powder, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-542(NDC:43386-312)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 335017 g  in 17 g
Product Characteristics
Colorwhite (white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-542-51510 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/201510/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09107701/01/201510/09/2022
Labeler - DirectRX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DirectRX079254320repack(61919-542)

Revised: 10/2023
 
DirectRX