GAVILAX - polyethylene glycol 3350 powder, for solution 
ATLANTIC BIOLOGICALS CORP.

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Drug Facts

Active Ingredient

Polyethylene Glycol 3350, 17 g (cap filled to line)

Purpose

Osmotic Laxative

Use

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

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

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

Keep out of the reach of children

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

Directions

Other Information

Inactive Ingredient

none

Questions or comments?

1-866-403-7592

GAVILAX (POLYETHYLENE GLYCOL-3350) POWDER, FOR SOLUTION

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GAVILAX  
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0312(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
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0312-117 g in 1 BAG; Type 0: Not a Combination Product01/26/2021
2NDC:17856-0312-28.5 g in 1 BAG; Type 0: Not a Combination Product01/26/2021
3NDC:17856-0312-317 g in 1 CUP; Type 0: Not a Combination Product01/26/2021
4NDC:17856-0312-44 g in 1 BAG; Type 0: Not a Combination Product01/26/2021
5NDC:17856-0312-550 in 1 CASE01/26/2021
58.5 g in 1 CUP; Type 0: Not a Combination Product
6NDC:17856-0312-672 in 1 CASE01/26/2021
64.5 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09107710/09/2009
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC BIOLOGICALS CORP.047437707RELABEL(17856-0312) , REPACK(17856-0312)

Revised: 1/2021
Document Id: aacfbecf-8d72-46f9-b315-ac2bf40c23aa
Set id: c9688f06-b6db-4afb-b8ff-ef5fb8bf9946
Version: 7
Effective Time: 20210126
 
ATLANTIC BIOLOGICALS CORP.