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Polyethylene Glycol 3350 by Strides Pharma Inc

Medically reviewed on August 30, 2018

Dosage form: powder, for solution
Ingredients: Polyethylene Glycol 3350 17g in 17g
Labeler: Strides Pharma Inc
NDC Code: 59556-762

Polyethelene Glycol 3350, Powder for Solution

Polyethylene Glycol 3350, Powder for SOlution

Drug Facts

Active ingredient (in each dose) (CAN Only)

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

‚ÄčPurpose

Osmotic Laxative

Active ingredient (in each dose) (Packet Only)

Polyethylene Glycol 3350, 17 g

Purpose

Osmotic Laxative

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days

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 (CAN Only)
  • 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 (white section in cap)
  • adults and children 17 years of age and older:
    • fill to top of white section 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

Direction (Packet Only)
  • do not take more than directed unless advised by your doctor
  • adults and children 17 years of age and older:
    • stir and dissolve one packet of powder (17 g) 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° to 25°C (68° to 77°F)
  • tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

INACTIVE INGREDIENT

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 Shasun Limited

Bangalore-560076, India

Distributed by

Strides Pharma Inc.

East Brunswick, NJ 08816

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10

Packets

NDC 64380-762-01

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool

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

  • Dissolves in any beverage
  • Sugar Free

10 ONCE-DAILY DOSES

10 PACKETS

NET WT 0.5 OZ (17g) EACH

10s carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

24

Packets

NDC 64380-762-02

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool

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

  • Dissolves in any beverage
  • Sugar Free

24 ONCE-DAILY DOSES

24 PACKETS

NET WT 0.5 OZ (17g) EACH

24s carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 64380-762-00

Original

Prescription

Strength

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool

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

  • Dissolves in any beverage
  • Sugar Free

1 DOSE

NET WT 0.5 OZ (17 g)

packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 64380-762-03

Original

Prescription

Strength

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool

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

  • Dissolves in any beverage
  • Sugar Free

7

ONCE-DAILY

DOSES

NET WT 4.15 OZ (119 g)

119 g CAN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 64380-762-04

Original

Prescription

Strength

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool

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

  • Dissoloves in any beverage
  • Sugar Free

14

ONCE-DAILY

DOSES

NET WT 8.3 OZ (238 g)

238 G CAN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 64380-762-05

Original

Prescription

Strength

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool

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

  • Dissolves in any beverage
  • Sugar Free

30

ONCE-DAILY

DOSES

NET WT 17.9 OZ (510 g)

510 g CAN

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-762
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 3350 (Polyethylene Glycol 3350) Polyethylene Glycol 335017 g  in 17 g
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (Colorless upon dissolution) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59556-762-04238 g in 1 CAN
2NDC:59556-762-03119 g in 1 CAN
3NDC:59556-762-05510 g in 1 CAN
4NDC:59556-762-0110 PACKET in 1 CARTON
4NDC:59556-762-0017 g in 1 PACKET
5NDC:59556-762-0224 PACKET in 1 CARTON
5NDC:59556-762-0017 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20392808/25/2016
Labeler - Strides Pharma Inc (078868278)
Establishment
NameAddressID/FEIOperations
Strides Shasun Limited918513263analysis(59556-762), manufacture(59556-762), pack(59556-762)

 
Strides Pharma Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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