GAVILAX
c9688f06-b6db-4afb-b8ff-ef5fb8bf9946
HUMAN OTC DRUG LABEL
Jun 23, 2025
ATLANTIC BIOLOGICALS CORP.
DUNS: 047437707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Polyethylene Glycol 3350
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (2)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
GAVILAX (POLYETHYLENE GLYCOL-3350) POWDER, FOR SOLUTION
INDICATIONS & USAGE SECTION
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:
- 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
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Polyethylene Glycol 3350, 17 g (cap filled to line)
OTC - PURPOSE SECTION
Purpose
Osmotic Laxative
Use
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 1 to 3 days
WARNINGS SECTION
Warnings
**Allergy alert:**Do not use if you are allergic to polyethylene glycol
Do not useif you have kidney disease, except under the advice and supervision of a doctor
OTC - ASK DOCTOR SECTION
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 productyou may have loose, watery, more frequent stools
DOSAGE & ADMINISTRATION SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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)
INACTIVE INGREDIENT SECTION
Inactive Ingredient
none
OTC - QUESTIONS SECTION
Questions or comments?
1-866-403-7592