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

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Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 grams (cap filled to the indicated "17 GRAMS" line)

Purpose

Laxative

Uses

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

none

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16 TH PLACE 

MIAMI, FL 33179

For serious adverse events call:

1-888-710-0006

Package label

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POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0489(NDC:57896-489)
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0489-150 in 1 BOX, UNIT-DOSE08/07/2018
117 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:17856-0489-272 in 1 BOX, UNIT-DOSE08/07/2018
217 g in 1 BAG; Type 0: Not a Combination Product
3NDC:17856-0489-372 in 1 BOX, UNIT-DOSE08/07/2018
34 g in 1 BAG; Type 0: Not a Combination Product
4NDC:17856-0489-472 in 1 BOX, UNIT-DOSE08/07/2018
44.25 g in 1 BAG; Type 0: Not a Combination Product
5NDC:17856-0489-550 in 1 BOX, UNIT-DOSE08/07/2018
58.5 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
6NDC:17856-0489-672 in 1 BOX, UNIT-DOSE08/07/2018
68.5 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09081208/07/2018
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC BIOLOGICALS CORP047437707relabel(17856-0489) , repack(17856-0489)

Revised: 8/2018
Document Id: b2c5b072-befa-48fc-a2cf-08cb3a0bd6f7
Set id: b4a571c7-230a-4955-875e-112cbe1f5596
Version: 1
Effective Time: 20180807
 
ATLANTIC BIOLOGICALS CORP.