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 LEADER/ CARDINAL HEALTH 110, INC., Aurohealth LLC, APL HEALTHCARE LIMITED, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, USP 17 grams

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
• adults and children 17 years of age and older:
  • use once a day
  • stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
  • do not combine with starch-based thickeners used for difficulty swallowing
  • ensure that the powder is fully dissolved before drinking
  • do not drink if there are any clumps
  • do not use 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 is open or broken

Inactive ingredients

none

Questions or comments?

call 1-855-274-4122

DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com  1-800-200-6313
Essential to Care™ since 1979

Made in India

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Label

LEADERTM

NDC: 70000-0699-1

Grit-Free | Unflavored Powder Packet
Polyethylene
Glycol 3350
Powder for Oral Solution
Osmotic Laxative

Relieves Occasional
Constipation/Irregularity
Softens Stool
Sugar-Free
Dissolves in any Beverage

COMPARE TO
MiraLAX®
active ingredient*

100% Money
Back Guarantee

1 DOSE
NET WT 0.5 OZ (17g)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Carton Label

LEADERTM

NDC: 70000-0699-2

Grit-Free | Unflavored Powder Packets
Polyethylene Glycol 3350
Powder for Oral Solution | Osmotic Laxative

Relieves Occasional Constipation/Irregularity
Softens Stool
Sugar-Free
Dissolves in Any Beverage

COMPARE TO
MiraLAX®
active ingredient*

100% Money
Back Guarantee

10 PRE-MEASURED, SINGLE DOSES                            10 PACKETS
10 ONCE-DAILY DOSES                                                    NET WT 0.5 OZ (17g) EACH

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0699
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: 70000-0699-2	10 in 1 CARTON	11/08/2024
1		17 g in 1 PACKET; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209017	11/08/2024

Labeler - LEADER/ CARDINAL HEALTH 110, INC. (063997360)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650844777	ANALYSIS(70000-0699) , MANUFACTURE(70000-0699)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		918917642	ANALYSIS(70000-0699) , MANUFACTURE(70000-0699)