MiraLAX
Polyethylene Glycol 3350 · Powder, For Solution · Oral
Active ingredient
Active ingredient (in each dose) (Bottle Only) Polyethylene Glycol 3350, 17 g (cap filled to line) Active ingredient (in each dose) (Packet Only) Polyethylene Glycol 3350, 17 g
Purpose
Purpose Osmotic Laxative Purpose Osmotic Laxative
Uses
Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
Warnings
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 if you have nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks irritable bowel syndrome Ask a doctor of pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools Stop use and ask a doctor if you have rectal bleeding or you nausea, bloating or 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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
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 a doctor or pharmacist
Ask a doctor of pharmacist before use if you are taking a prescription drug
When using this product
When using this product you may have loose, watery, more frequent stools
Stop use and ask a doctor
Stop use and ask a doctor if you have rectal bleeding or you nausea, bloating or 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
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Directions (Bottle Only) do not take more than directed unless advised by your doctor the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap) adults and children 17 years of age and older: use once a day fill to top of white section in cap which is marked to indicate the correct dose (17 g) 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 Directions (Packet Only) 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
Other information store at 20°-25°C (68°-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
Inactive ingredients none
Questions?
Questions or comments? 1-800-MiraLAX (1-800-647-2529)
Label text from the FDA structured product label by Bayer HealthCare LLC. (revised May 4, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Polyethylene Glycol 3350 in 4 products
MiraLAX NDC products (4)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 76420-489 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | ASCLEMED USA INC. | NDA |
| 11523-4357 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Bayer HealthCare LLC. | NDA |
| 11523-7268 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Bayer HealthCare LLC. | NDA |
| 55154-5035 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Cardinal Health 107, LLC | NDA |
MiraLAX recalls
- D-1319-2022 Aug 17, 2022 · Class II · Terminated
CGMP Deviations: products were stored outside the drug label specifications.
Frequently asked questions
What is MiraLAX used for?
Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
Who makes MiraLAX?
MiraLAX is listed by 3 labelers in the FDA NDC directory, including ASCLEMED USA INC., Bayer HealthCare LLC., Cardinal Health 107, LLC.
Has MiraLAX been recalled?
The FDA enforcement database lists 1 recall for MiraLAX, most recently D-1319-2022 (class ii): CGMP Deviations: products were stored outside the drug label specifications.