POLYETHYLENE GLYCOL- polyethylene glycol powder, for solution 
Harmon Stores, Inc

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Polyethylene Glycol 3350 powder for solution

Drug Facts

Active ingredient (in each dose)

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

  • nausea, vomiting or abdominal pain
  • a sudden change in bowel habits that lasts over 2 weeks
  • irritable bowel syndrome

Ask a doctor of 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

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.

Directions

Other information

Inactive Ingredient

none

Questions or comments?

1-877-753-3935

Made in India

*Miralax® is a registered trademark of Bayer Consumer Care Holdings LLC

Distributed by Liberty

Procurement, Inc.650 Liberty

Ave. Union, NJ 07083 USA

Visit us at: www.facevalues.com

Revised: 01/2017

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63940-762-03

Polyethylene Glycol 3350

Powder for Solution

OSMOTIC LAXATIVE

Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.

TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

7 Once-Daily Doses

NET WT 4.15 OZ (119 g)

peg-119g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63940-762-04

Polyethylene Glycol 3350

Powder for Solution

OSMOTIC LAXATIVE

Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.

TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

14 Once-Daily Doses

NET WT 8.3 OZ (238 g)

peg-238g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63940-762-05

Polyethylene Glycol 3350

Powder for Solution

OSMOTIC LAXATIVE

Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.

TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

30 Once-Daily Doses

NET WT 17.9 OZ (510 g)

peg-510g
POLYETHYLENE GLYCOL 
polyethylene glycol powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-762
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 ((colorless upon dissolution)) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-762-03119 g in 1 BOTTLE; Type 0: Not a Combination Product08/24/2016
2NDC:63940-762-04238 g in 1 BOTTLE; Type 0: Not a Combination Product08/24/2016
3NDC:63940-762-05510 g in 1 BOTTLE; Type 0: Not a Combination Product08/24/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20392808/24/2016
Labeler - Harmon Stores, Inc (804085293)
Registrant - Strides Shasun Limited (918513263)
Establishment
NameAddressID/FEIBusiness Operations
Strides Shasun Limited918513263ANALYSIS(63940-762) , MANUFACTURE(63940-762) , PACK(63940-762)

Revised: 5/2017
Document Id: 6b9592f2-983d-462f-90a2-c288bc8f6657
Set id: 3fd415b7-3d17-47ff-86b1-9eeac5f20271
Version: 1
Effective Time: 20170504
 
Harmon Stores, Inc