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FDA Drug information

GAVILAX

Read time: 1 mins
Marketing start date: 05 May 2024
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Summary of product characteristics


Dosage And Administration

DOSAGE & ADMINISTRATION SECTION 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: 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 use once a day use no 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 is missing, open or broken

Warnings

WARNINGS SECTION 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 Close

Effective Time

20230112

Version

5

Purpose

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

Spl Product Data Elements

GAVILAX GAVILAX POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 white

Application Number

ANDA091077

Brand Name

GAVILAX

Generic Name

GAVILAX

Product Ndc

61919-542

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL image description

Ask Doctor

OTC - ASK DOCTOR SECTION 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

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION In case of overdose, get medical help or contact a POISON CONTROL CENTER right away. (1-800-222-1222)

Stop Use

OTC - STOP USE SECTION 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.

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Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

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Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.