POLYETHYLENE GLYCOL 3350 - polyethylene glycol 3350 powder, for solution 
Strides Pharma Inc

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Polyethelene Glycol 3350, Powder for Solution

Polyethylene Glycol 3350, Powder for Solution

Drug Facts

Active ingedient (in each dose) (Can only)

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

Purpose

Osmotic Laxative

Active ingredient (in each dose) (Packet Only)

Polyethylene Glycol 3350, 17 g

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 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

  • 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 (Can Only)

Directions (Packet Only)

  • do not take more than directed unless advised by your doctor
  • adults and children 17 years of age and older:
    • use once a day
    • stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • do not combine with starch-based thickeners used for difficulty swallowing
    • ensure that the powder is fully dissolved before drinking
    • do not drink if there are any clumps
    • do not use more than 7 days
  • children 16 years of age or under: ask a doctor

Other Information

Inactive ingredients

none

Questions or comments?

1-877-244-9825

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

Manufactured by:

Strides Pharma Science Limited                                                               

Bengaluru – 5562106, India.

Distributed by

Strides Pharma Inc.

East Brunswick, NJ 08816

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10

Packets

NDC 59556-762-01

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

TAMPER-EVIDENT: DO NOT USE IF FOIL IS OPEN OR BROKEN

10 ONCE-DAILY DOSES

10 PACKETS

NET WT 0.5 OZ (17g) EACH

10 packets in a carton

10s carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

24

Packets

NDC 59556-762-02

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

TAMPER-EVIDENT: DO NOT USE IF FOIL IS OPEN OR BROKEN

24 ONCE-DAILY DOSES

24 PACKETS

NET WT 0.5 OZ (17g) EACH

24 packets in a carton

24s carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59556-762-00

Original

Prescription

Strength

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

TAMPER-EVIDENT: DO NOT USE IF FOIL IS OPEN OR BROKEN

1 DOSE

NET WT 0.5 OZ (17 g)

Packet

packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59556-762-03

Original

Prescription

Strength

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

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)

119 g CAN - FRONT

119 g CAN - FRONT

119 g BASE LABEL

119 g BACK [CAN]

119g BACK LABEL

119g BACK [CAN]

119g BACK LABEL

119g BACK [CAN]

119g BACK LABEL

119g BACK [CAN]

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59556-762-04

Original

Prescription

Strength

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

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)

238 G FRONT LABEL

238 G CAN - FRONT

238g BACK LABEL

238 G CAN - BACK

CAN - BACK LABEL

238 G CAN - BACK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59556-762-05

Original

Prescription

Strength

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

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)

510 g FRONT LABEL

510 g CAN - FRONT

CAN - BACK

510 g CAN - BACK

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-762
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:59556-762-04238 g in 1 CAN; Type 0: Not a Combination Product08/25/2016
2NDC:59556-762-03119 g in 1 CAN; Type 0: Not a Combination Product08/25/2016
3NDC:59556-762-05510 g in 1 CAN; Type 0: Not a Combination Product08/25/2016
4NDC:59556-762-0224 in 1 CARTON08/25/2016
4NDC:59556-762-0017 g in 1 PACKET; Type 0: Not a Combination Product
5NDC:59556-762-0110 in 1 CARTON08/25/2016
5NDC:59556-762-0017 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20392808/25/2016
Labeler - Strides Pharma Inc (078868278)
Establishment
NameAddressID/FEIBusiness Operations
Strides Pharma Science Limited918513263ANALYSIS(59556-762) , MANUFACTURE(59556-762) , PACK(59556-762)

Revised: 2/2022
Document Id: 27cb56bb-5999-476f-913a-e739f568bd6e
Set id: 77b9060f-c9ab-4047-b1f1-063956678453
Version: 5
Effective Time: 20220218
 
Strides Pharma Inc