POLYETHYLENE GLYCOL 3350 powder, for solution

Polyethylene Glycol 3350 by

Drug Labeling and Warnings

Polyethylene Glycol 3350 by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, Aurobindo Pharma Limited, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, USP 17 grams (cup filled to the indicated 17 grams line)

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

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking a prescription drug

WHEN USING

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

PREGNANCY OR BREAST FEEDING

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 (1-800-222-1222) right away.

Directions

• do not take more than directed unless advised by your doctor
• this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line
• adults and children 17 years of age and older:
  • fill to the indicated 17 grams line on cup which is marked to indicate the correct dose 17 grams
  • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
  • ensure that the powder is fully dissolved before drinking
  • do not drink if there are any clumps
  • 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 ingredients

none

Questions or comments?

call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/19/1993

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 119 g Bottle Label

AUROHEALTH

NDC: 58602-805-01

Compare to active ingredient
of MiraLax®*

Polyethylene Glycol 3350
Powder for Oral Solution

Osmotic Laxative

• Relieves Occasional Constipation/Irregularity
• Softens Stool

UNFLAVORED POWDER - GRIT FREE

7 ONCE-DAILY DOSES        NET WT 4.1 OZ (119 g)
 

 

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-805
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	17 g  in 17 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-805-01	119 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package	04/09/2018
2	NDC: 58602-805-02	238 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package	04/09/2018
3	NDC: 58602-805-03	510 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package	04/09/2018
4	NDC: 58602-805-04	850 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package	04/09/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209017	04/09/2018

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		918917642	ANALYSIS(58602-805) , MANUFACTURE(58602-805)