Drugplain

GAVILAX 17 g/17g

Polyethylene Glycol 3350 · POWDER, FOR SOLUTION · ATLANTIC BIOLOGICALS CORP.

No Recall History
Plain English

GAVILAX is a powder, for solution containing polyethylene glycol 3350 at 17 g/17g, taken oral. Manufactured by ATLANTIC BIOLOGICALS CORP..

Key Facts

Brand Name
GAVILAX
Generic Name
Polyethylene Glycol 3350
NDC Code (Product)
17856-0312
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Strength
17 g/17g
Dosage Form
POWDER, FOR SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA091077
Drug Class
Osmotic Laxative [EPC]
Marketing Start
01/26/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective1,781 reports
off label use1,287 reports
incorrect product administration duration1,266 reports
nausea929 reports
diarrhoea882 reports
constipation700 reports
vomiting640 reports
incorrect drug administration duration625 reports
underdose597 reports
abdominal pain594 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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. adults and children 17 years of age and older: use once a day fill to top of line 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 Other Information store at 20°- 25°C (68°– 77°F) tamper-evident: do not use if printed foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Dosage & Administration

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.

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

Frequently Asked Questions

What is GAVILAX used for?

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

Is GAVILAX a controlled substance?

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

What is the generic name for GAVILAX?

The generic name for GAVILAX is Polyethylene Glycol 3350. There are 11 other brand versions of Polyethylene Glycol 3350.

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

The NDC (National Drug Code) for GAVILAX 17 g/17g is 17856-0312, listed by ATLANTIC BIOLOGICALS CORP..

Product NDC

17856-0312

Package NDC

17856-0312-1

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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)