POLYETHYLENE GLYCOL 3350- polyethylene glycol 3350 powder, for solution 
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

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Drug Facts
Active ingredient (in each dose)
Polyethylene Glycol 3350, 17 g (cap filled to line)
Purpose
Osmotic Laxative

INDICATIONS AND 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 at1-800-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 at1-800-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 ofage or under: ask a doctor

Other information

  • store at 20o- 25oC (68o-77oF)
  • 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 DRUGItem Code (Source)NDC:14539-150
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
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; Type 0: Not a Combination Product09/28/201109/29/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20207109/28/201109/29/2011
Labeler - Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (780779901)
Registrant - Emcure Pharmaceuticals Limited (916921919)
Establishment
NameAddressID/FEIBusiness Operations
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.189630168ANALYSIS(14539-150) , LABEL(14539-150) , MANUFACTURE(14539-150) , PACK(14539-150)

Revised: 2/2020
 
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.