Your browser does not support JavaScript! POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [EMCURE PHARMACEUTICALS USA INC.]
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POLYETHYLENE GLYCOL 3350 powder, for solution
[Emcure Pharmaceuticals USA Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

INDICATIONS & USAGE

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 or 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
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088

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

  • 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 (17g)
    • 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

 

Other information

  • store at 20°-25°C (68°-77°F)
  • tamper-evident : do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken

Inactive ingredients               none

 

Principal display panel


Base panel
Polyethylene Glycol 3350 NF
Powder for Solution, Osmotic Laxative
 
  • Relieves Occasional Constipation (Irregularity)
  • Softens Stools

 
NDC 14539-150-20
Original Prescription Strength
Dissolves in Any Beverage
30 ONCE-DAILY DOSES
Net Wt. 510 g
Polyethylene Glycol 3350 NF increases frequency of bowel movements and softens the stools.
 
Manufactured By:
Emcure Pharmaceuticals USA Inc.
21/B Cotters Lane
East Brunswick, NJ 08816, USA.
 
Top panel
Polyethylene Glycol 3350 NF
Powder for Solution, Osmotic Laxative
 
  • Relieves Occasional Constipation (Irregularity)
  • Softens Stools

 
NDC 14539-150-20
PEEL HERE
Original Prescription Strength
30 ONCE-DAILY DOSES
Net Wt. 510 g
 
Drug Facts
Active ingredient (in each dose) Purpose
Polyethylene Glycol 3350,
17 g (cap filled to line).............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 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
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088

 

If Pregnant or breast-feeding, ask a health professional before use. 

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


Directions
 
  • 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 (17g)
    • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • use once a day
    • use not more than 7 days
  • children 16 years of age or under: ask a doctor 

Other information
  • store at 20o- 25 oC (68o-77o F)
  • tamper- evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken 

 
Inactive ingredients    none
 
Label

 
 
 
 
 
 
POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:14539-150
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 335017 g
Product Characteristics
ColorWHITE (Colorless upon dissolution) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14539-150-2030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20207109/28/2011
Labeler - Emcure Pharmaceuticals USA Inc. (189630168)
Establishment
NameAddressID/FEIBusiness Operations
Emcure Pharmaceuticals USA Inc.189630168ANALYSIS(14539-150), MANUFACTURE(14539-150)

Revised: 1/2013
 
Emcure Pharmaceuticals USA Inc.

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