Checked
Comfortlax
polyethylene glycol 3350 · Comfortlax is an osmotic laxative (over-the-counter) containing polyethylene glycol 3350, made by Family Dollar Stores, LLC.
- Type
- Over the counter
- Drug class
- Osmotic Laxative
- Route
- Oral
- Manufacturers
- 1
relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
Drug facts
- Generic name
- polyethylene glycol 3350
- Active ingredients
- Polyethylene Glycol 3350
- Drug class
- Osmotic Laxative
- How it works
- Osmotic Activity
- Dosage forms
- Powder, for solution
- Label holder
- Family Dollar Stores, LLC
- FDA application
- ANDA209017
- Label updated
- 04/23/2026
Active ingredients
Drug Facts Active ingredient (in each dose) Polyethylene Glycol 3350, USP 17 grams (cup filled to the indicated 17 grams line)
Purpose
Osmotic Laxative
Uses
Relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
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: use once a day 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 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 no more than 7 days children 16 years of age or under: ask a doctor
Warnings
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 before use
Nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks irritable bowel syndrome
Ask a doctor or pharmacist before use
Taking a prescription drug
When using this product
You may have loose, watery, more frequent stools
Stop use and ask a doctor
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 breastfeeding
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.
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: MIDWOOD BRANDS, LLC 500 VOLVO PKWY CHESAPEAKE, VA 23320 USA MADE IN INDIA Code: TS/DRUGS/16/2014
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Powder, for solution | 17 g/17g | oral | 1 |
Manufacturers and labels
1 FDA label
- Family Dollar Stores, LLCShown hereANDA209017 · Label 04/23/2026 · NDC 55319-056Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrug08/17/2022Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT...Mckesson Medical-Surgical Inc. Corporate Office · CGMP Deviations: products were stored outside the drug label...
- Class IIDrug05/25/2022GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack...Lupin Pharmaceuticals Inc. · Failed Stability Specification
- Class IIDrug06/02/2021Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses NDC...Cardinal Health Inc. · 2 products · CGMP Deviations: Intermittent exposure to temperature excursion...
- Class IIIDrug07/11/2018Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a)...LUPIN SOMERSET · Labeling: Not Elsewhere Classified - A private label distributor...
- Class IIDrug05/16/2018Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57Kroger Specialty Pharmacy, Inc. · Lack of Processing Controls.
Comfortlax: common questions
- What is Comfortlax used for?
- relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
- Is Comfortlax a prescription drug?
- No. Comfortlax is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Comfortlax?
- Yes. Other FDA-listed products with the same active ingredients include Clearlax, Polyethylene Glycol 3350, Nf Powder for Solution, Laxative, clear lax, dg health clearlax.
- Who makes Comfortlax?
- Family Dollar Stores, LLC lists Comfortlax with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 04/23/2026 · Label text is shown as published by the manufacturer. Not medical advice