Polyethylene Glycol 400
Active ingredient
Sold as Systane · blink tears · Systane Ultra · Systane Lubricant · Archies Dry Eye Relief
- Drug class
- -
- Availability
- Over-the-counter
- Routes
- Ophthalmic
- Markets covered
- 2
- Products on record
- 17
- FDA reports (12 mo)
- 1,633
Overview
Plain-language summary, compiled from the cited regulatory records
Polyethylene Glycol 400 is an active ingredient used for protection against further irritation and for the temporary relief of burning and irritation associated with dry eyes [1]. It is available in the market under various brand names, including Systane Ultra and blink tears [1].
In the past 12 months, there have been 1,633 adverse event reports associated with products containing Polyethylene Glycol 400 [2]. The most frequently reported adverse events include claims of the drug being ineffective, off-label use, incorrect administration duration, headache, and diarrhea [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 15 | December 30, 2025 |
| CA Canada | Health Canada | 2 | September 12, 2025 |
USUnited States· FDA
15 products
Uses
Uses for protection against further irritation for temporary relief of burning and irritation due to dryness of the eye
How to take
Directions instill 1 to 2 drops in the affected eye(s) as needed
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 1,633 reports total. [3]
- Drug Ineffective 228
- Off Label Use 173
- Incorrect Product Administration Duration 140
- Headache 124
- Diarrhoea 102
- Drug Intolerance 88
- Constipation 87
- Nausea 82
- Condition Aggravated 81
- Fatigue 80
- Underdose 74
- Inappropriate Schedule Of Product Administration 69
Side effects & warnings
Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours
Warnings For external use only Do not use this product if solution changes color or becomes cloudy When using this product to avoid contamination, do not touch tip of container to any surface. Replace cap after using. remove contact lenses before using Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
Do not use this product if solution changes color or becomes cloudy
This is not medical advice. Consult a qualified healthcare professional.
CACanada· Health Canada
2 products
2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [2].
Brands in Canada (2)
Sources & citations
- [1]FDA DailyMed · 0018ade9-5856-db… · revised December 30, 2025 [PDF]
- [2]Health Canada (DPD) · 02518201 · revised September 12, 2025
- [3]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.