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Polyethylene Glycol 3350 by Strides Pharma Inc

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

← See all Polyethylene Glycol 3350 brands

Medically reviewed on Aug 30, 2018

Further information

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

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