Drugplain

MiraLAX 17 g/17g

Polyethylene Glycol 3350 · POWDER, FOR SOLUTION · Bayer HealthCare LLC.

2 Recalls on Record
Plain English

MiraLAX is a powder, for solution containing polyethylene glycol 3350 at 17 g/17g, taken oral. Manufactured by Bayer HealthCare LLC..

Key Facts

Brand Name
MiraLAX
Generic Name
Polyethylene Glycol 3350
NDC Code (Product)
11523-4357
Manufacturer
Bayer HealthCare LLC.
Strength
17 g/17g
Dosage Form
POWDER, FOR SOLUTION
Route
ORAL
Marketing Status
Application #
NDA022015
Drug Class
Osmotic Laxative [EPC]
Marketing Start
02/01/2007

Recall History

2 Recalls on Record
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

product use issue9,866 reports
drug ineffective9,435 reports
off label use8,859 reports
diarrhoea6,600 reports
nausea4,983 reports
constipation4,787 reports
fatigue4,289 reports
product use in unapproved indication3,636 reports
vomiting3,025 reports
incorrect drug administration duration2,828 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days

Dosage & Administration

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 more than 7 days children 16 years of age or under: ask a doctor

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(1-800-222-1222).

Frequently Asked Questions

What is MiraLAX used for?

MiraLAX contains Polyethylene Glycol 3350. It is a powder, for solution taken oral. Consult your doctor for specific uses.

Is MiraLAX a controlled substance?

MiraLAX is not classified as a controlled substance by the DEA.

What is the generic name for MiraLAX?

The generic name for MiraLAX is Polyethylene Glycol 3350. There are 10 other brand versions of Polyethylene Glycol 3350.

What is the NDC code for MiraLAX 17 g/17g?

The NDC (National Drug Code) for MiraLAX 17 g/17g is 11523-4357, listed by Bayer HealthCare LLC..

Product NDC

11523-4357

Package NDC

11523-4357-2

Other Polyethylene Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)