leader clearlax 17 g/17g

Polyethylene Glycol 3350 · POWDER, FOR SOLUTION · Cardinal Health 110, LLC. dba Leader

No Recall History

Plain English

leader clearlax is a powder, for solution containing polyethylene glycol 3350 at 17 g/17g, taken oral. Manufactured by Cardinal Health 110, LLC. dba Leader.

Key Facts

Brand Name: leader clearlax
Generic Name: Polyethylene Glycol 3350
NDC Code (Product): 70000-0415
Manufacturer: Cardinal Health 110, LLC. dba Leader
Strength: 17 g/17g
Dosage Form: POWDER, FOR SOLUTION
Route: ORAL
Marketing Status
Application #: ANDA090685
Drug Class: Osmotic Laxative [EPC]
Marketing Start: 12/27/2018

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective1,740 reports

off label use1,268 reports

incorrect product administration duration1,265 reports

nausea911 reports

diarrhoea868 reports

constipation682 reports

incorrect drug administration duration625 reports

vomiting619 reports

underdose596 reports

abdominal pain587 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 • 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: • 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 • ensure that the powder is fully dissolved before drinking • do not drink if there any clumps • use once a day • use no 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 or 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 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 If pregnant or breast-feeding, 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 right away. (1-800-222-1222)

Frequently Asked Questions

What is leader clearlax used for?

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

Is leader clearlax a controlled substance?

leader clearlax is not classified as a controlled substance by the DEA.

What is the generic name for leader clearlax?

The generic name for leader clearlax is Polyethylene Glycol 3350. There are 12 other brand versions of Polyethylene Glycol 3350.

What is the NDC code for leader clearlax 17 g/17g?

The NDC (National Drug Code) for leader clearlax 17 g/17g is 70000-0415, listed by Cardinal Health 110, LLC. dba Leader.

Product NDC

70000-0415

Package NDC

70000-0415-1

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)