Drug Facts
Active ingredient (in each dose)
Polyethylene Glycol 3350, USP 17 g (cap filled to line)
The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Polyethylene Glycol 3350 (NDC 58602-910). 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.
Active ingredient (in each dose)
Polyethylene Glycol 3350, USP 17 g (cap filled to line)
Osmotic Laxative
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 or pharmacist before use if you are taking a prescription drug
When using this product you may have loose, watery, more frequent stools
If pregnant or breast-feeding, ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
orange flavor (contains dl-alpha-tocopherol and maize maltodextrin) and sucralose.
Questions or comments?
call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road,
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/16/2014
AUROHEALTH
NDC 58602-910-01
Compare to active ingredient
of MiraLax®*
Polyethylene Glycol 3350
Powder for Oral Solution
Osmotic Laxative
Orange Flavor GRIT-FREE POWDER
7 ONCE-DAILY DOSES NET WT 4.1 OZ (119 g)
AUROHEALTH
NDC 58602-910-26
Compare to active ingredient
of MiraLax®*
Polyethylene Glycol 3350
Powder for Oral Solution
Osmotic Laxative
Orange Flavor
GRIT-FREE POWDER
1 DOSE
NET WT 0.5 oz (17 g)
AUROHEALTH
NDC 58602-910-37
Compare to active ingredient
of MiraLax®*
Polyethylene Glycol 3350
Powder for Oral Solution
Osmotic Laxative
Polyethylene Glycol 3350 powder for
oral solution increases frequency of
bowel movements and softness the stool.
Orange Flavor
GRIT-FREE POWDER
10 PRE-MEASURED, SINGLE DOSES
10 ONCE-DAILY DOSES
10 Packets
NET WT 0.5 oz (17 g) Each
* Please review the disclaimer below.