Drug Facts
Active ingredient (in each dose)
Polyethylene Glycol 3350, USP 17 grams
Polyethylene Glycol 3350 Powder, For Solution
FDA Label NDC 70000-0699
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Polyethylene Glycol 3350 (NDC 70000-0699). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, use, warnings, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug
Otc - 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
Otc - 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 Package Label-principal Display Panel (17 g Pouch Label)
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 Package Label-principal Display Panel (17 g Pouch Carton Label)
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 
* Please review the disclaimer below.
